Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-05 @ 8:52 AM
Study NCT ID:
NCT02202850
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2014-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Defining Remission With Etanercept in AS in Real Life Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 12', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.", 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 18, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cervical dysplasia', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large Intestinal Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '4.95', 'upperLimit': '31.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS partial remission was defined as a score of less than or equal to (\\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '62.6'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 5/6 was defined as at least greater than or equal to (\\>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '47.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 60 was defined as at least \\>= 60 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '50.5'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 40 was defined as at least \\>= 40 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '45.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \\>=50 percent relative improvement from baseline in BASDAI total score.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '28.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '3.21', 'upperLimit': '37.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 up to Month 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.19', 'upperLimit': '26.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '6.76', 'upperLimit': '34.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '34.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '36.8'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '57.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS partial remission was defined as a score of \\<= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '68.6'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '71.6'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '65.7'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '76.7'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '4.33', 'upperLimit': '77.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '76.6'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '97.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 5/6 was defined as at least \\>= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '46.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '50.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '52.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '45.5'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '57.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 60 was defined as at least \\>= 60 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '54.2'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '3.67', 'upperLimit': '71.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '59.3'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '71.6'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '65.7'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '64.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '30.7', 'upperLimit': '62.6'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '9.90', 'upperLimit': '81.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 40 was defined as at least \\>= 40 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '57.9'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '57.9'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '48.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '52.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '64.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '57.9'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '3.19', 'upperLimit': '65.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \\>=50 percent relative improvement from baseline in BASDAI total score.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '42.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '6.06', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '48.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '47.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '4.54', 'upperLimit': '36.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '5.73', 'upperLimit': '43.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '45.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '7.45', 'upperLimit': '37.5'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.61', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.62', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.40', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.90', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '2.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.98', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.07', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '2.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and12', 'description': 'Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.49', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '6.06', 'spread': '4.83', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '46.86', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.50', 'spread': '14.70', 'groupId': 'OG000'}, {'value': '-2.03', 'spread': '9.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is a protein marker in the blood for inflammation.', 'unitOfMeasure': 'milligrams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spinal Mobility Measurement at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.04', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '10.80', 'spread': '4.51', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.73', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '4.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.45', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.16', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.73', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'FG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Enbrel treatment discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept First Cohort', 'description': "Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'BG001', 'title': 'Etanercept Second Cohort', 'description': "Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.83', 'spread': '13.84', 'groupId': 'BG000'}, {'value': '41.37', 'spread': '9.74', 'groupId': 'BG001'}, {'value': '42.58', 'spread': '13.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Baseline analysis set (BAS) included all randomized participants enrolled in the study who were present at baseline, whether from first or second cohort.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-20', 'size': 1808132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-23T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2014-07-23', 'resultsFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2014-07-25', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-23', 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS partial remission was defined as a score of less than or equal to (\\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 5/6 was defined as at least greater than or equal to (\\>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 60 was defined as at least \\>= 60 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': 'ASAS 40 was defined as at least \\>= 40 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).'}, {'measure': 'Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \\>=50 percent relative improvement from baseline in BASDAI total score."}, {'measure': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}, {'measure': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12', 'timeFrame': 'Month 6 up to Month 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS partial remission was defined as a score of \\<= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 5/6 was defined as at least \\>= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 60 was defined as at least \\>= 60 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).'}, {'measure': 'Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': 'ASAS 40 was defined as at least \\>= 40 percent relative improvement from baseline and an absolute change \\>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).'}, {'measure': 'Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \\>=50 percent relative improvement from baseline in BASDAI total score."}, {'measure': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}, {'measure': 'Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12', 'timeFrame': 'Month 3, 6, 9 and 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}, {'measure': 'Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.'}, {'measure': 'Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.'}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.'}, {'measure': 'Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and12', 'description': 'Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is a protein marker in the blood for inflammation.'}, {'measure': 'Change From Baseline in Spinal Mobility Measurement at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.'}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity."}, {'measure': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}, {'measure': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12', 'timeFrame': 'Baseline, Month 6 and 12', 'description': "ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \\<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801379&StudyName=Defining%20remission%20with%20etanercept%20in%20AS%20in%20real%20life%20clinical%20practice', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Determine which remission criterion at Month 6 predicts remission at Month 12 the best.', 'detailedDescription': 'The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.\n\nThis analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.\n\nIn this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop-out rate of 30% over 1 year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting Rheumatologist for which the decision has been taken to prescribe Etanercept as first or second line', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC.\n\n 1. First cohort: Etanercept is the first biological product prescribed\n 2. Second cohort: Etanercept is the second biological product prescribed\n2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.\n3. 18 years of age or older at time of consent\n4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n1\\. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent."}, 'identificationModule': {'nctId': 'NCT02202850', 'acronym': 'REACH AS', 'briefTitle': 'Defining Remission With Etanercept in AS in Real Life Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))', 'orgStudyIdInfo': {'id': 'B1801379'}, 'secondaryIdInfos': [{'id': 'B1801379', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': 'REACH-AS', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Etanercept First', 'description': 'Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium', 'interventionNames': ['Drug: etanercept']}, {'label': 'Etanercept second', 'description': 'Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium', 'interventionNames': ['Drug: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'DRUG', 'description': 'etanercept 1 x 50 mg/week or 2 x 25mg/week', 'armGroupLabels': ['Etanercept First']}, {'name': 'etanercept', 'type': 'DRUG', 'description': 'etanercept 1 x 50 mg/week or 2 x 25mg/week', 'armGroupLabels': ['Etanercept second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'state': 'Bruxelles-capitale, Région de', 'country': 'Belgium', 'facility': 'CHU Brugmann - 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