The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
NCT ID: NCT01533714
Last Updated: 2022-05-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
103 participants
INTERVENTIONAL
2012-01-26
2013-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDP6038 (olokizumab)
CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083).
CDP6038 (olokizumab)
Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
Interventions
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CDP6038 (olokizumab)
Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
Eligibility Criteria
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Inclusion Criteria
* Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 \[NCT01463059\], and plan to maintain this same dose and route of administration for at least 12 weeks
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Exclusion Criteria
* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
* Have evidence of active or latent tuberculosis (TB)
* Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
* Subject has planned surgery during the first 12 weeks of the study
* Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 \[NCT01463059\] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 \[NCT01463059\]
20 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tsutomu Takeuchi, Professor
Role: PRINCIPAL_INVESTIGATOR
Keio University
Locations
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102
Chiba, , Japan
114
Fukuoka, , Japan
115
Fukuoka, , Japan
113
Hiroshima, , Japan
120
Kakogawa, , Japan
118
Kumamoto, , Japan
116
Kurume, , Japan
122
Matsuyama, , Japan
107
Nagaoka, , Japan
110
Nagoya, , Japan
103
Narita, , Japan
112
Okayama, , Japan
119
Ōita, , Japan
100
Sapporo, , Japan
117
Sasebo, , Japan
123
Tokyo, , Japan
101
Tomakomai, , Japan
108
Tonami, , Japan
111
Tsu, , Japan
105
Yokohama, , Japan
104
Yotukaido, , Japan
200
Daejeon, , South Korea
201
Junggu, , South Korea
202
Seongdong-Gu, , South Korea
203
Seoul, , South Korea
204
Seoul, , South Korea
301
Taichung, , Taiwan
306
Taichung, , Taiwan
307
Taichung, , Taiwan
302
Taipei, , Taiwan
308
Taipei, , Taiwan
309
Taipei, , Taiwan
Countries
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Other Identifiers
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RA0089
Identifier Type: -
Identifier Source: org_study_id
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