EUCTR2012-003655-11-HU进行中（未招募）1 期
A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 739
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 principle inclusion criteria are:
- •1-Male or female subjects who are =18 years of age, having completed
- •one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-
- •204 and, who in the opinion of the investigator, will continue to benefit
- •from treatment in the extension study.
- •2. Females of childbearing potential must continue using highly effective
- •methods of birth control during the study and for at least 12 weeks after
- •the last dose of study medication (or longer if required by local
- •regulations).
- •3-Sexually active men must agree to use a highly effective method of
- •contraception (e.g. double barrier) during the study and continue its use
- •for at least 12 weeks after the last dose of study medication.
- •Please see study protocol 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 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •The principle exclusion criteria are:
- •1-Subjects who had been prematurely withdrawn from one of the 2 core
- •(GLPG0634-CL-203 or GLPG0634-CL-204), for any reason, including
- •fulfilling the individual stopping criteria.
- •2. Subjects who are deemed not to be benefiting from the study
- •medication based
- •upon lack of improvement or worsening of their symptoms. Local
- •guidelines for subject treatment need to be followed.
- •3. Subjects with persistent abnormal laboratory values, associated with
- •the study medication (including but not limited to hematology, liver and
- •renal function values) during one of the 2 core studies (GLPG0634-CL-
- •203 and GLPG0634-CL-204), according to the investigator's clinical
- •Please see study protocol for full details
研究者
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