PER-057-13未知未知
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE IIB DOSE FINDING STUDY OF GLPG0634 ADMINISTERED FOR 24 WEEKS IN COMBINATION WITH METHOTREXATE TO SUBJECTS WITHMODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO METHOTREXATE ALONE
Galapagos N.V,0 个研究点目标入组 0 人开始时间: 2014年1月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- All
入选标准
- •Male or female subjects who are ≥18 years of age,
- •on the day of signing informed consent,
- •Have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and
- •ACR functional class I-III,
- •Have ≥6 swollen joints (from a 66 joint count) and
- •≥8 tender joints (from a 68 joint count) at Screening
- •and at Baseline,
- •Screening serum c-reactive protein ≥1.5 x upper
- •limit of laboratory normal range (ULN),
- •Have received MTX for ≥6 months and have been
- •on a stable dose (15 to 25 mg/week) of MTX for at
- •least 4 weeks prior to Screening and willing to
- •continue on their current 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
排除标准
- •Current therapy with any disease-modifying
- •anti-rheumatic drugs (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,
- •Current or previous RA treatment with a biologic
- •DMARD, with the exception of biologic DMARDs
- •administered in a single clinical study setting more
- •than 6 months prior to Screening (12 months for
- •rituximab or other B cell depleting agents), where
- •the biologic DMARD was effective, and if
- •discontinued, this should not be due to lack of
- •Previous treatment at any time with a cytotoxic
- •agent, other than MTX, before Screening.
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