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临床试验/NCT01533714
NCT01533714终止2 期

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

UCB BIOSCIENCES, Inc.32 个研究点 分布在 3 个国家目标入组 103 人开始时间: 2012年1月26日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
103
试验地点
32
主要终点
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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].

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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]

研究组 & 干预措施

CDP6038 (olokizumab)

Experimental

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).

干预措施: CDP6038 (olokizumab) (Biological)

结局指标

主要结局

Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

时间窗: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)

Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.

次要结局

  • 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(Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • 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(Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089))
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089))
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089(Week 12 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089(Week 24 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089(Week 48 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089(Week 96 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089(Week 12 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089(Week 24 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089(Week 48 (Study RA0089))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089(Week 96 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089))
  • Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089(Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089))
  • Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120(Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120)
  • Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120(Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (32)

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