EUCTR2011-005008-14-HU进行中（未招募）不适用
Randomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone
Galapagos SAS0 个研究点目标入组 90 人开始时间: 2012年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1. Male or female subjects who are 18 to 70 years of age, on the day of signing informed consent.
- •2. Fulfill the revised 1987 American Rheumatism Association (ARA) criteria (Appendix 1) for the classification of RA.
- •3. Have = 5 swollen joints (from a 66 joint count) and = 5 tender joints (from a 68 joint count), and a serum CRP =1.0 mg/dL.
- •4. Have received MTX for > 12 weeks and be on a stable dose (7.5 mg/week to 25 mg/week [extremes included]) of MTX for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study.
- •5. If taking oral steroids, these should be at a dose =10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening.
- •6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening.
- •7. The results of the following laboratory tests performed at the central laboratory at screening must be within the limits specified below:
- •a. Hemoglobin =8.5 g/dL (International System of Units [SI]: =85 g/L);
- •b. White blood cells =3.0 x 103 cells/mm3 (SI: =3.0 x 109 cells/L);
- •c. Neutrophils =1.5 x 103 cells/mm3 (SI: =1.5 x 109 cells/L);
- •d. Platelets =100 x 103 cells/mm3 (SI: =100 x 109 cells/L);
- •e. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5 x upper limit of laboratory normal range (ULN); and
- •f. Total bilirubin level =1.25 x ULN;
- •g. Lipase and amylase within normal range.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Current therapy with any disease modifying anti-rheumatic drug (DMARD) other than MTX, including oral or injectable gold, sulfasalazine, hydroxychloroquine, azathioprine, or D penicillamine within four weeks prior to screening, cyclosporine within eight weeks prior to screening, and leflunomide within three months prior to screening.
- •2. Current or previous RA treatment with a biological agent, with the exception of biologics administered in a single clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents).
- •3. Previous treatment at any time with a cytotoxic agent, other than MTX, before screening. These agents include, but are not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
- •4. Previous use of the study drug, GLPG0634.
- •5. Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening.
研究者
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