EUCTR2014-003033-26-ES进行中（未招募）1 期
A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ablynx NV
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The main criteria for inclusion include the following:
- •? Man or woman ? 18 years and < 75 years of age at the time of signing the informed consent form.
- •? Diagnosis of RA for at least 6 months prior to screening, and ACR functional class I-III.
- •? Treated with and tolerating MTX
- •? Active RA
- •A complete list of selection criteria can be found in the body of the Clinical Study Protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 314
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •The main criteria for exclusion include the following:
- •? Have been treated with DMARDs/systemic immunosuppressives other than MTX.
- •? Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
- •? Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs for RA.
- •? Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.
- •A complete list of selection criteria can be found in the body of the Clinical Study Protocol.
研究者
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