EUCTR2012-003635-31-AT进行中（未招募）不适用
Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 595
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
- •To be eligible for study entry subjects must fulfil all of the following criteria:
- •1. Male or female subjects who are =18 years of age, on the day of signing informed consent.
- •2. Diagnosis of RA since at least 6 months prior to Screening and
- •meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III.
- •3. Have =6 swollen joints (from a 66 joint count) and =8 tender joints (from a 68 joint count) at Screening and Baseline, and a Screening serum CRP =0.70 x upper limit of the normal (reference) laboratory range (ULN).
- •4. Have received MTX (oral or parenteral) for =6 months and have been on a stable dose (15 mg/week
- •to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on this
- •regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed, when
- •there is documented evidence of intolerance or safety issues at higher doses.
- •5. If taking oral steroids, these should be at a dose =10 mg/day of prednisone or prednisone
- •equivalent and stable for at least 4 weeks prior to Baseline.
- •6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at
- •least 2 weeks prior to Baseline.
- •Please see study protcol for full details
- •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 475
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Subjects will be excluded from the study if one or more of the following statements are applicable:
- •1. Current therapy with any DMARD other than MTX, including oral or
- •injectable gold, sulfasalazine, antimalarials, azathioprine, or D-penicillamine
- •within 4 weeks prior to Baseline, cyclosporine within 8
- •weeks prior to Baseline, and leflunomide within 3 months prior to
- •Baseline or a minimum 4 weeks prior to
- •Baseline if after 11 days of standard cholestyramine therapy.
- •2. Current or previous RA treatment with a biologic DMARD, with the
- •exception of biologic DMARDs administered in a single clinical study
- •setting, and; more than 6 months prior to Screening (12 months for
- •rituximab or other B cell depleting agents), and; where the biologic
- •DMARD was effective, and if discontinued, this should not be due to lack
- •of efficacy.
- •Please see study protocol for full details
研究者
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