Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 8:31 PM
Study NCT ID:
NCT01463059
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2011-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000592400', 'term': 'olokizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'dispFirstSubmitDate': '2013-03-19', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-19', 'studyFirstSubmitDate': '2011-10-27', 'dispFirstSubmitQcDate': '2013-03-19', 'studyFirstSubmitQcDate': '2011-10-27', 'dispFirstPostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12', 'timeFrame': 'From Week 0 (Baseline) to Week 12'}], 'secondaryOutcomes': [{'measure': 'Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12', 'timeFrame': 'From Week 0 (Baseline) to Week 12', 'description': 'Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.'}, {'measure': 'Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12', 'timeFrame': 'From Week 0 (Baseline) to Week 12', 'description': 'Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.'}, {'measure': 'Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12', 'timeFrame': 'From Week 0 (Baseline) to Week 12', 'description': 'Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Monoclonal Antibody', 'Interleukin-6', 'Olokizumab', 'CDP6038'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26358841', 'type': 'DERIVED', 'citation': 'Takeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, Park W, Shiozawa K, Tsukano M, Wei JC, Shao J, Togo O, Mashimo H. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15-23. doi: 10.3109/14397595.2015.1074648. Epub 2015 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA\n* Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR \\>28mm/hour\n* Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration\n* Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening\n* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception\n\nExclusion Criteria:\n\n* Have a diagnosis of any other inflammatory arthritis\n* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks\n* Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)\n* Subjects with known concurrent acute or chronic viral hepatitis B or C infection\n* Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection\n* Subjects with known history of or current clinically active infection\n* Subjects at high risk of infection\n* Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection\n* Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)\n* Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening"}, 'identificationModule': {'nctId': 'NCT01463059', 'briefTitle': 'Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy', 'orgStudyIdInfo': {'id': 'RA0083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo every 2 weeks', 'description': 'Injections administered at week 0, 2, 4, 6, 8 and 10', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Olokizumab 60 mg every 2 weeks', 'description': 'Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10', 'interventionNames': ['Biological: Olokizumab 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Olokizumab 60 mg every 4 weeks', 'description': 'Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10', 'interventionNames': ['Biological: Placebo', 'Biological: Olokizumab 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Olokizumab 120 mg every 2 weeks', 'description': 'Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10', 'interventionNames': ['Biological: Olokizumab 120 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Olokizumab 120 mg every 4 weeks', 'description': 'Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10', 'interventionNames': ['Biological: Placebo', 'Biological: Olokizumab 120 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Olokizumab 240 mg very 4 weeks', 'description': 'Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10', 'interventionNames': ['Biological: Placebo', 'Biological: Olokizumab 240 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo solution for injection, administered as subcutaneous injections', 'armGroupLabels': ['Olokizumab 120 mg every 4 weeks', 'Olokizumab 240 mg very 4 weeks', 'Olokizumab 60 mg every 4 weeks', 'Placebo every 2 weeks']}, {'name': 'Olokizumab 60 mg', 'type': 'BIOLOGICAL', 'otherNames': ['CDP6038'], 'description': 'Olokizumab 60 mg solution for injection, administered as subcutaneous injections', 'armGroupLabels': ['Olokizumab 60 mg every 2 weeks', 'Olokizumab 60 mg every 4 weeks']}, {'name': 'Olokizumab 120 mg', 'type': 'BIOLOGICAL', 'otherNames': ['CDP6038'], 'description': 'Olokizumab 120 mg solution for injection, administered as subcutaneous injections', 'armGroupLabels': ['Olokizumab 120 mg every 2 weeks', 'Olokizumab 120 mg every 4 weeks']}, {'name': 'Olokizumab 240 mg', 'type': 'BIOLOGICAL', 'otherNames': ['CDP6038'], 'description': 'Olokizumab 240 mg solution for injection, administered as subcutaneous injections', 'armGroupLabels': ['Olokizumab 240 mg very 4 weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba', 'country': 'Japan', 'facility': '102', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '114', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '115', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': '113', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kakogawa', 'country': 'Japan', 'facility': '120', 'geoPoint': {'lat': 34.76943, 'lon': 134.82905}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': '118', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kurume', 'country': 'Japan', 'facility': '116', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': '121', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': '122', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Nagaoka', 'country': 'Japan', 'facility': '107', 'geoPoint': {'lat': 37.45, 'lon': 138.85}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': '110', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Narita', 'country': 'Japan', 'facility': '103', 'geoPoint': {'lat': 35.78333, 'lon': 140.31667}}, {'city': 'Okayama', 'country': 'Japan', 'facility': '112', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Ōita', 'country': 'Japan', 'facility': '119', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': '100', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sasebo', 'country': 'Japan', 'facility': '117', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'city': 'Tokorozawa', 'country': 'Japan', 'facility': '124', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': '123', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tomakomai', 'country': 'Japan', 'facility': '101', 'geoPoint': {'lat': 42.63694, 'lon': 141.60333}}, {'city': 'Tonami', 'country': 'Japan', 'facility': '108', 'geoPoint': {'lat': 36.62047, 'lon': 136.94321}}, {'city': 'Tsu', 'country': 'Japan', 'facility': '111', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': '105', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yotukaido', 'country': 'Japan', 'facility': '104'}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': '200', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Junggu', 'country': 'South Korea', 'facility': '201', 'geoPoint': {'lat': 37.69175, 'lon': 126.60024}}, {'city': 'Seongdong-gu', 'country': 'South Korea', 'facility': '202'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '203', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '204', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Changhua', 'country': 'Taiwan', 'facility': '303', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Dalin-Town', 'country': 'Taiwan', 'facility': '304'}, {'city': 'Hualien City', 'country': 'Taiwan', 'facility': '305', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': '300', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': '301', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': '306', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': '307', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': '302', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': '308', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': '309', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': '310', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Japan Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}