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临床试验/NCT01296711
NCT01296711终止2 期

A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056

UCB BIOSCIENCES, Inc.55 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2011年3月7日最近更新:
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适应症

试验速览

阶段
2 期
状态
终止
入组人数
190
试验地点
55
主要终点
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
研究概览研究设计入排标准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 who completed study RA0056 (NCT01242488).

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 two weeks, for the treatment of active rheumatoid arthritis.

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
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subject completed the RA0056 study (Week 12 Visit)
  • •Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, 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 an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
  • •Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
  • •Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)

排除标准

  • •Subject has an ongoing serious adverse event from the RA0056 study
  • •Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
  • •Subject has evidence of active or latent tuberculosis
  • •Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
  • •Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
  • •Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study

结局指标

主要结局

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

时间窗: From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)

Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.

次要结局

  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057))
  • The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057))
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057))
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057(Week 24 (Study RA0057))
  • The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057))
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057))
  • The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057))
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057(Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057(Week 12 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057(Week 48 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057(Week 96 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057(Week 12 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057(Week 24 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057(Week 48 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057))
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057(Week 96 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057))
  • Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057(Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (55)

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