Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00851318
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2009-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}, {'id': 'D008727', 'term': 'Methotrexate'}], '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'}, {'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': {'email': 'ClinicalTrials.Disclosure@astellas.com', 'title': 'Medical Director, Global Medical Sciences', 'organization': 'Astellas Pharma Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.', 'description': 'All participants who received at least one study drug administration were included in the safety analysis population (SAF).', 'eventGroups': [{'id': 'EG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'otherNumAtRisk': 81, 'otherNumAffected': 77, 'seriousNumAtRisk': 81, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'otherNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'otherNumAtRisk': 93, 'otherNumAffected': 91, 'seriousNumAtRisk': 93, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'otherNumAtRisk': 92, 'otherNumAffected': 90, 'seriousNumAtRisk': 92, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anovulatory cycle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal vestibulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 92, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngeal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Removal of internal fixation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Mild adverse events', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Moderate adverse events', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Non-fatal serious adverse events', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events leading to withdrawal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Infections induced by pathogen in study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overdoses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events occurring within 2 hours of dosing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:\n\nMild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.\n\nA serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one study drug administration were included in the safety analysis population (SAF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '81.1'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '43.4', 'upperLimit': '87.4'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '90.9', 'upperLimit': '99.3'}, {'value': '98.9', 'groupId': 'OG003', 'lowerLimit': '94.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '85.2'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '96.6'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.2', 'upperLimit': '100.0'}, {'value': '94.6', 'groupId': 'OG003', 'lowerLimit': '87.8', 'upperLimit': '98.2'}]}]}, {'title': 'Final Assessment', 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '88.3'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '66.9', 'upperLimit': '98.7'}, {'value': '95.7', 'groupId': 'OG002', 'lowerLimit': '89.4', 'upperLimit': '98.8'}, {'value': '94.6', 'groupId': 'OG003', 'lowerLimit': '87.8', 'upperLimit': '98.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 20% improvement in 68 tender joint count;\n* ≥ 20% improvement in 66 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '53.5'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '61.6'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '74.8', 'upperLimit': '90.7'}, {'value': '82.6', 'groupId': 'OG003', 'lowerLimit': '73.3', 'upperLimit': '89.7'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '59.5'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '33.5', 'upperLimit': '79.7'}, {'value': '87.1', 'groupId': 'OG002', 'lowerLimit': '78.5', 'upperLimit': '93.2'}, {'value': '88.0', 'groupId': 'OG003', 'lowerLimit': '79.6', 'upperLimit': '93.9'}]}]}, {'title': 'Final Assessment', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '71.2'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '33.5', 'upperLimit': '79.7'}, {'value': '86.0', 'groupId': 'OG002', 'lowerLimit': '77.3', 'upperLimit': '92.3'}, {'value': '85.9', 'groupId': 'OG003', 'lowerLimit': '77.0', 'upperLimit': '92.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 50% improvement in 68 tender joint count;\n* ≥ 50% improvement in 66 swollen joint count; and\n* ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '24.4'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '51.2'}, {'value': '60.2', 'groupId': 'OG002', 'lowerLimit': '49.5', 'upperLimit': '70.2'}, {'value': '47.8', 'groupId': 'OG003', 'lowerLimit': '37.3', 'upperLimit': '58.5'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '42.1'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '56.6'}, {'value': '64.5', 'groupId': 'OG002', 'lowerLimit': '53.9', 'upperLimit': '74.2'}, {'value': '57.6', 'groupId': 'OG003', 'lowerLimit': '46.9', 'upperLimit': '67.9'}]}]}, {'title': 'Final Assessment', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '55.9'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '56.6'}, {'value': '65.6', 'groupId': 'OG002', 'lowerLimit': '55.0', 'upperLimit': '75.1'}, {'value': '62.0', 'groupId': 'OG003', 'lowerLimit': '51.2', 'upperLimit': '71.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 70% improvement in 68 tender joint count;\n* ≥ 70% improvement in 66 swollen joint count; and\n* ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS) 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-2.28', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '-3.24', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '-3.23', 'spread': '1.24', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-2.65', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '-3.51', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '-3.21', 'spread': '1.29', 'groupId': 'OG003'}]}]}, {'title': 'Final Assessment', 'categories': [{'measurements': [{'value': '-2.98', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.49', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '-3.46', 'spread': '1.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count;\n* 28 swollen joint count;\n* Erythrocyte sedimentation rate (ESR);\n* Patient's global assessment of disease activity.\n\nTo obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.\n\nThe data before study drug administration of 275-08-001 Study was utilized for Baseline.\n\nDAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp Score (mTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'OG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'classes': [{'title': 'Change from Baseline to Week 0', 'categories': [{'measurements': [{'value': '1.48', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '1.83', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 100 (N=61, 16, 83, 83', 'categories': [{'measurements': [{'value': '5.13', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '8.79', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '12.43', 'groupId': 'OG002'}, {'value': '2.12', 'spread': '9.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100', 'description': 'X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.\n\nThe degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.\n\nThe joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available mTSS data. Linear extrapolation method was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'FG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'FG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'FG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '92'}]}, {'type': 'Completed Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '87'}]}, {'type': 'Completed Week 52', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Non-compliance with Study Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients with rheumatoid arthritis (RA) who participated in Study 275-08-001 (NCT00791999) were eligible for this study.', 'preAssignmentDetails': 'Participants were assigned to treatment groups based on whether they discontinued study 275-08-001 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '285', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Discontinued Non-responders 200 mg', 'description': 'Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'BG001', 'title': 'Completed Non-responders 200 mg', 'description': 'Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'BG002', 'title': 'Completed Responders 200 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'BG003', 'title': 'Completed Responders 400 mg', 'description': 'Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '52.8', 'spread': '11.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '245', 'groupId': 'BG004'}]}]}, {'title': '≧ 65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '285', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '56.30', 'spread': '12.00', 'groupId': 'BG000'}, {'value': '54.27', 'spread': '9.57', 'groupId': 'BG001'}, {'value': '55.81', 'spread': '11.34', 'groupId': 'BG002'}, {'value': '54.92', 'spread': '9.47', 'groupId': 'BG003'}, {'value': '55.56', 'spread': '10.83', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2009-02-23', 'resultsFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-09', 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:\n\nMild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.\n\nA serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 20% improvement in 68 tender joint count;\n* ≥ 20% improvement in 66 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP)."}, {'measure': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) Response', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 50% improvement in 68 tender joint count;\n* ≥ 50% improvement in 66 swollen joint count; and\n* ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP)."}, {'measure': 'Percentage of Participants With American College of Rheumatology 70% (ACR70) Response', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:\n\n* ≥ 70% improvement in 68 tender joint count;\n* ≥ 70% improvement in 66 swollen joint count; and\n* ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));\n * C-Reactive Protein (CRP)."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS) 28', 'timeFrame': 'Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count;\n* 28 swollen joint count;\n* Erythrocyte sedimentation rate (ESR);\n* Patient's global assessment of disease activity.\n\nTo obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.\n\nThe data before study drug administration of 275-08-001 Study was utilized for Baseline.\n\nDAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."}, {'measure': 'Change From Baseline in Modified Total Sharp Score (mTSS)', 'timeFrame': 'Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100', 'description': 'X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.\n\nThe degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.\n\nThe joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Certolizumab Pegol', 'Cimzia'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-001.', 'detailedDescription': 'This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who participated in Study 275-08-001 and meet all of the criteria described below.\n\n * Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week 24.\n * Patients who are able to receive treatment with MTX, by Week 52.\n\nExclusion Criteria:\n\n* Patients who experienced an important protocol deviation as mentioned below during Study 275-08-001.\n* Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).\n* Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.\n* Patients who required treatment for the same infection at two or more different times during Study 275-08-001\n* Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.\n* Patients whom the investigator has decided to be inappropriate for participation in the study'}, 'identificationModule': {'nctId': 'NCT00851318', 'briefTitle': 'Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)', 'orgStudyIdInfo': {'id': 'CDP870-275-08-002'}, 'secondaryIdInfos': [{'id': 'JapicCTI-090700'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certolizumab pegol 200 mg', 'description': 'Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'interventionNames': ['Drug: Certolizumab pegol', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Certolizumab pegol 400 mg', 'description': 'Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.', 'interventionNames': ['Drug: Certolizumab pegol', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Certolizumab pegol', 'type': 'DRUG', 'otherNames': ['CDP870', 'Cimzia'], 'description': 'Subcutaneous (SC) injection', 'armGroupLabels': ['Certolizumab pegol 200 mg', 'Certolizumab pegol 400 mg']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate dose between 6 to 8 mg/week.', 'armGroupLabels': ['Certolizumab pegol 200 mg', 'Certolizumab pegol 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Region', 'country': 'Japan'}, {'city': 'Chugoku Region', 'country': 'Japan'}, {'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UCB Japan Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}