Clinical trial NCT01533714: The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
Official title: Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Monoclonal antibody
Interleukin-6
Olokizumab
CDP6038
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: R-Pharm
First posted: 2012-02-15
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 \[NCT01463059\].

Detailed description: Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.

Eligibility criteria: Inclusion Criteria:

* Completed the RA0083 \[NCT01463059\] study (Week 12 Visit)
* 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:

* Have an ongoing SAE from the RA0083 \[NCT01463059\] study
* 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 \[NCT01463059\]

Primary outcomes:
measure: Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Secondary outcomes:
measure: Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
timeFrame: Week 12 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
timeFrame: Week 24 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
timeFrame: Week 48 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
timeFrame: Week 96 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
timeFrame: Week 12 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
timeFrame: Week 24 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
timeFrame: Week 48 (Study RA0089)
measure: Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
timeFrame: Week 96 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
measure: Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
timeFrame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
measure: Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
timeFrame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
measure: Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
timeFrame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: 102
city: Fukuoka
country: Japan
facility: 114
city: Fukuoka
country: Japan
facility: 115
city: Hiroshima
country: Japan
facility: 113
city: Kakogawa
country: Japan
facility: 120
city: Kumamoto
country: Japan
facility: 118
city: Kurume
country: Japan
facility: 116
city: Matsuyama
country: Japan
facility: 122
city: Nagaoka
country: Japan
facility: 107
city: Nagoya
country: Japan
facility: 110
city: Narita
country: Japan
facility: 103
city: Oita
country: Japan
facility: 119
city: Okayama
country: Japan
facility: 112
city: Sapporo
country: Japan
facility: 100
city: Sasebo
country: Japan
facility: 117
city: Tokyo
country: Japan
facility: 123
city: Tomakomai
country: Japan
facility: 101
city: Tonami
country: Japan
facility: 108
city: Tsu
country: Japan
facility: 111
city: Yokohama
country: Japan
facility: 105
city: Yotukaido
country: Japan
facility: 104
city: Daejeon
country: Korea, Republic of
facility: 200
city: Jung-Gu
country: Korea, Republic of
facility: 201
city: Seongdong-Gu
country: Korea, Republic of
facility: 202
city: Seoul
country: Korea, Republic of
facility: 203
city: Seoul
country: Korea, Republic of
facility: 204
city: Taichung
country: Taiwan
facility: 301
city: Taichung
country: Taiwan
facility: 306
city: Taichung
country: Taiwan
facility: 307
city: Taipei
country: Taiwan
facility: 302
city: Taipei
country: Taiwan
facility: 308
city: Taipei
country: Taiwan
facility: 309
Study officials:
affiliation: Keio University
name: Tsutomu Takeuchi, Professor
role: PRINCIPAL_INVESTIGATOR
References: