Viewing Study NCT00760669

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Ignite Creation Date: 2025-12-24 @ 11:14 PM
Ignite Modification Date: 2026-01-03 @ 1:05 PM
Study NCT ID: NCT00760669
Status: COMPLETED
Last Update Posted: 2013-10-29
First Post: 2008-09-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], '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'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D019370', 'term': 'Observation'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+82-2-2094-4879', 'title': 'Clinical Research Associate', 'organization': 'Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea'}, 'certainAgreement': {'otherDetails': "Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 30 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.', 'otherNumAtRisk': 1055, 'otherNumAffected': 95, 'seriousNumAtRisk': 1055, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'LE cells present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Spinal shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.52', 'spread': '6.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 30', 'categories': [{'measurements': [{'value': '-5.23', 'spread': '4.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '60.75', 'spread': '29.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 30', 'categories': [{'measurements': [{'value': '-21.80', 'spread': '29.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.', 'unitOfMeasure': 'Millimeter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.94', 'spread': '14.04', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 30', 'categories': [{'measurements': [{'value': '-4.81', 'spread': '11.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'Milligram per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Number of Swollen Joints at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.75', 'spread': '6.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 30', 'categories': [{'measurements': [{'value': '-5.46', 'spread': '6.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.', 'unitOfMeasure': 'Swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Number of Tender Joints at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.31', 'spread': '7.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 30', 'categories': [{'measurements': [{'value': '-7.35', 'spread': '7.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.', 'unitOfMeasure': 'Tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'timeFrame': 'Baseline and Week 30', 'description': 'The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section \\* area score \\* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.'}, {'type': 'PRIMARY', 'title': 'Overall Efficacy Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1031', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '948', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Aggravated', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': "The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '106', 'spread': '7.75', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '12', 'spread': '7.42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unexpected Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '7.42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '7.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 30', 'description': 'An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1061'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1031'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Not assessed for overall improvement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Participants missing efficacy assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Participants with overlapping cases', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Took drug before entering in contract', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Receiving Infliximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.32', 'spread': '13.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '363', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '692', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were performed on safety analysis set. Data presented only for 1055 participants as they were part of safety analysis set. Safety analysis set included all participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1061}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2008-09-24', 'resultsFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-06', 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).'}, {'measure': 'Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline in Number of Swollen Joints at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.'}, {'measure': 'Change From Baseline in Number of Tender Joints at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.'}, {'measure': 'Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section \\* area score \\* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).'}, {'measure': 'Overall Efficacy Assessment', 'timeFrame': 'Baseline up to Week 30', 'description': "The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion."}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Week 30', 'description': 'An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With Unexpected Adverse Events', 'timeFrame': 'Baseline up to Week 30', 'description': 'Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.'}, {'measure': 'Number of Participants With Adverse Drug Reactions', 'timeFrame': 'Baseline up to Week 30', 'description': 'Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".'}, {'measure': 'Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction', 'timeFrame': 'Baseline up to Week 30', 'description': 'An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spondylitis, Ankylosing', 'Arthritis, Rheumatoid', 'Psoriasis', 'Arthritis, Psoriatic', 'Infliximab', 'Remicade'], 'conditions': ['Spondylitis, Ankylosing', 'Arthritis, Rheumatoid', 'Psoriasis', 'Arthritis, Psoriatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.', 'detailedDescription': "This is an observational, prospective (study following participants forward in time) study to assess safety and efficacy of infliximab injection under post-marketing use and identify problems related to adverse events in participants with ankylosing spondylitis (chronic inflammatory condition affecting the axial joints), rheumatoid arthritis (chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures), psoriasis (scaly skin rash) and psoriatic arthritis (a type of inflammatory arthritis associated with psoriasis). Participants with rheumatoid arthritis will receive 6 doses of infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6 and will be observed for 30 weeks; and those with ankylosing spondylitis, psoriasis and psoriatic arthritis will also receive 6 doses of injection and will be observed for 24 to 30 weeks. Efficacy will be evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP), Psoriasis Area and Severity Index (PASI), swollen joint counts and tender joint count. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participant with ankylosing spondylitis, rheumatoid arthritis, psoriasis and psoriatic arthritis will be observed at rheumatology departments in university or general hospitals where they are commonly treated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation\n* Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate\n* Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD\n* Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA)\n* Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00760669', 'briefTitle': 'An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients', 'orgStudyIdInfo': {'id': 'CR100768'}, 'secondaryIdInfos': [{'id': 'REMICADEAKS4004', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants Receiving Infiximab', 'description': 'Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving infliximab injection will be observed.', 'interventionNames': ['Drug: Infliximab; observational study', 'Drug: Methotrexate; observational study']}], 'interventions': [{'name': 'Infliximab; observational study', 'type': 'DRUG', 'otherNames': ['Remicade Injection'], 'description': 'This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.', 'armGroupLabels': ['Participants Receiving Infiximab']}, {'name': 'Methotrexate; observational study', 'type': 'DRUG', 'description': "Participants with RA will receive methotrexate based on physician's clinical judgement.", 'armGroupLabels': ['Participants Receiving Infiximab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Korea, Ltd., Korea Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd., Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}