Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 3:28 AM
Study NCT ID:
NCT00993668
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB, Inc'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event (AE) data summarized in the first two columns refer to the 6-week Single-Blind (SB) period of the study. The final column refers to AE data collected on subjects who received Cimzia at any time during the study (up to 42 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Single Blind)', 'description': 'Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4', 'otherNumAtRisk': 114, 'otherNumAffected': 29, 'seriousNumAtRisk': 114, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cimzia (Single Blind)', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4', 'otherNumAtRisk': 110, 'otherNumAffected': 22, 'seriousNumAtRisk': 110, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cimzia at Any Time', 'description': 'Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).', 'otherNumAtRisk': 219, 'otherNumAffected': 155, 'seriousNumAtRisk': 219, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 32, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 71, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Latent Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chest Wall Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chordoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Depressed Level Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '72.6'}, {'value': '54.5', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '64.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '71.9'}, {'value': '53.5', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '64.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '67.4'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '43.8', 'upperLimit': '62.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000', 'lowerLimit': '44.8', 'upperLimit': '63.5'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '59.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '68.5'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '39.4', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '83.0'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '74.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '74.3'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '53.4', 'upperLimit': '71.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '85.0'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '79.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'title': 'Concomitant MTX Use (n=60, 63)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '37.3', 'upperLimit': '62.7'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '32.2', 'upperLimit': '56.7'}]}]}, {'title': 'No Concomitant MTX Use (n=28, 25)', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '100.00'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '95.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'OG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'classes': [{'title': 'Concomitant MTX Use (n=57, 59)', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '63.9'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '33.1', 'upperLimit': '58.5'}]}]}, {'title': 'No Concomitant MTX Use (n=26, 27)', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '98.5'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '87.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of single blind period (Week 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'FG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}], 'periods': [{'title': 'Single-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 subject chose not to enter the optional open-label period', 'groupId': 'FG000', 'numSubjects': '109'}, {'comment': '1 subject chose not to enter the optional open-label period', 'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study started in September of 2009 with recruitment occurring in the United States. The primary outcome completed in June 2010 and the open-label extension completed in February 2011.', 'preAssignmentDetails': 'Treatment column headings reflect the treatment received in the Single-Blind (SB) period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).'}, {'id': 'BG001', 'title': 'Cimzia', 'description': 'Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.65', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '53.05', 'spread': '11.78', 'groupId': 'BG001'}, {'value': '52.85', 'spread': '11.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'nctId': 'NCT03559686', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2009-10-09', 'resultsFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-23', 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.', 'timeFrame': 'Baseline, End of single blind period (Week 6)'}, {'measure': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.', 'timeFrame': 'Baseline, End of single blind period (Week 6)'}], 'secondaryOutcomes': [{'measure': 'Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.', 'timeFrame': 'End of single blind period (Week 6)'}, {'measure': 'Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.', 'timeFrame': 'End of single blind period (Week 6)'}, {'measure': 'Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.', 'timeFrame': 'Baseline, End of single blind period (Week 6)'}, {'measure': 'Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.', 'timeFrame': 'Baseline, End of single blind period (week 6)'}, {'measure': 'Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.', 'timeFrame': 'End of single blind period (Week 6)'}, {'measure': 'Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.', 'timeFrame': 'End of single blind period (Week 6)'}, {'measure': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.', 'timeFrame': 'Baseline, End of single blind period (Week 6)'}, {'measure': 'Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.', 'timeFrame': 'Baseline, End of single blind period (Week 6)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza', 'vaccine', 'pneumococcal vaccine', 'certolizumab pegol', 'Cimzia'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24584918', 'type': 'DERIVED', 'citation': 'Kivitz AJ, Schechtman J, Texter M, Fichtner A, de Longueville M, Chartash EK. Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single-blind randomized phase IV trial. J Rheumatol. 2014 Apr;41(4):648-57. doi: 10.3899/jrheum.130945. Epub 2014 Mar 1.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be at least 18 years old at the screening visit\n* Subjects must be able to understand the information provided to them and to give written informed consent, and be able and willing to comply with the study requirements\n* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide. Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 10 weeks after the last dose of CZP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for 10 weeks after the subject receives their last dose of CZP\n* Subjects must have a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 6-months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria\n* Subjects must have active RA disease as defined by: ≥ 4 tender joints (28 joint count) at Screening and Week 0; and ≥ 4 swollen joints (28 joint count) at Screening and Week 0\n\nExclusion Criteria:\n\n* Subjects who have a diagnosis of any other inflammatory arthritis (eg., psoriatic arthritis or ankylosing spondylitis)\n* Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ\n* Subjects must be free of defined prohibited medication and biological therapy\n* Subjects who have received any experimental nonbiological therapy, within or outside of a clinical trial in the 3 months prior to Week 0\n* Subjects who have received any experimental biological agent in the past 3 months or within 5 half-lives prior to Week 0 (whichever is longer)\n* Subjects who have received previous treatment with biological response modifier therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.\n* Subjects with a history of pneumococcal or influenza infection in the last 3 months\n* Subjects with a history of pneumococcal vaccination in the last 5 years\n* Subjects with a history of influenza vaccination within the last 6 months\n* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the trial or within 3 months following last dose of study drug\n* Subjects with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection\n* Subjects who have had a splenectomy\n* Subjects who have had a hypersensitivity reaction to previous pneumococcal or influenza vaccination\n* Subjects who have a known hypersensitivity to eggs and egg products or to other components of the vaccine\n* Subjects with a history of Guillain-Barre syndrome\n* Subjects with a history of tuberculosis, active tuberculosis, positive chest x-ray for tuberculosis, or positive purified protein derivative (PPD) skin test (defined as induration of ≥5 mm). Subjects who are not candidates for PPD testing due to prior severe reaction to the PPD test or a history of PPD positivity must undergo an Elispot test instead for tuberculosis evaluation. Subjects testing positive via the PPD or having an indeterminate or positive Elispot test, or for which latent tuberculosis cannot be ruled out, may be enrolled in the study provided that they are treated (eg., isoniazid for 9 months) and that their treatment has been initiated at least 4 weeks prior to the first administration of CZP\n* Subjects at high risk of infection (eg., presence of leg ulcers or an indwelling urinary catheter, persistent or recurrent chest infections, bedridden or wheelchair bound subjects)\n* Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease\n* Subjects with known concurrent acute or chronic viral hepatitis B or C or positive hepatitis B surface antigen (HBs-Ag) or hepatitis C virus antibody (HCV-Ab)\n* Subjects with known human immunodeficiency virus (HIV) infection\n* Subjects receiving any live or attenuated vaccination within 12 weeks prior to Week 0\n* Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to screening)\n* Subjects with Class III or Class IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria\n* Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg., multiple sclerosis or optic neuritis)\n* Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease\n* Subjects with any other condition (eg., clinically significant laboratory values) which in the Investigator's judgement would make the subject unsuitable for inclusion in the study\n* Subjects with a history of an adverse reaction to polyethylene glycol (PEG)"}, 'identificationModule': {'nctId': 'NCT00993668', 'briefTitle': 'Assessing the Use of 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