A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biotest
- 入组人数
- 127
- 试验地点
- 39
- 主要终点
- dose-response information
研究概览
简要总结
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (MTX).
详细描述
Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a double-blind set-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
- •Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
- •Duration of RA more than 12 month
- •History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
- •MTX treatment at least 6 month with a stable dose at least 15mg MTX
- •Patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline
- •Written Informed Consent
排除标准
- •Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
- •Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
- •treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
- •Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
结局指标
主要结局
dose-response information
时间窗: ACR20 response at week 13 (1 week after last dose of study drug)
ACR20 response (percentage of patients reaching or exceeding at least a 20% improvement in their arthritis assessment according to the criteria of the American College of Rheumatology)
次要结局
- Safety and tolerability of the various dose levels and of placebo(weekly assessment of physical status, safety labs, adverse events during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug)
- Pharmakokinetics (PK)(weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug)
- efficacy responses other than ACR20, including questionaires, and their dose dependencies(weekly assessment of ACR arthritis status during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug)