EUCTR2012-003655-11-CZ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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •1. Male or female subjects who are =18 years of age, having completed the
- •qualifying core study GLPG0634-CL-203 and, who in the opinion of the
- •investigator, will continue to benefit from treatment in the extension study.
- •2. Female subjects of childbearing potential who engage in heterosexual
- •intercourse must agree to use protocol specified method (s)
- •of contraception and agree to refrain from egg donation and in vitro
- •fertilization as described in the protocol.
- •3- Fertile male subjects who engage in heterosexual intercourse must
- •agree to use protocol specified method(s) of contraception and agree to
- •refrain from sperm donation as described in the protocol.
- •4. Able and willing to sign the informed consent as approved by the
- •Independent Ethics Committee (IEC)/Institutional Review Board (IRB),
- •prior to the Entry visit and agree to the schedule of assessments.
- •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 Subjects who had been prematurely withdrawn from the core study (GLPG0634-CL-203), for any reason, including fulfilling the individual stopping
- •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 use of
- •the study medication (including but not limited to hematology, liver and renal
- •function values) during the core study GLPG0634-CL-203, according to the
- •investigator’s clinical judgment.
- •4. Subjects who require immunization with live/live attenuated vaccine.
- •5. Subjects with diagnosis since the inclusion to GLPG0634-CL-203 core study of rheumatic autoimmune disease or inflammatory joint disease other than RA, except for secondary
- •Sjögren's syndrome.
- •6. Subjects with symptoms suggestive of moderate to severe congestive
- •heart failure or major cerebrovascular event since the inclusion to
- •GLPG0634-CL-203 core study.
- •7. Subjects with symptoms suggestive of GI tract ulceration and/or
- •active diverticulitis since the inclusion to GLPG0634-CL-203 core study.
- •8. Subjects with symptoms suggestive of possible lymphoproliferative
- •disease including lymphadenopathy or splenomegaly since the inclusion
- •to GLPG0634-CL-203 core study.
- •9. Subjects with symptoms suggestive of malignancy since the inclusion
- •to GLPG0634-CL-203 core study.
- •10. If applicable to national or local legislation: history of being admitted
- •to an institution under administrative or court order since the inclusion
- •to GLPG0634-CL-203 core study.
- •11. History of drug and alcohol abuse since the inclusion to GLPG0634-
- •CL-203 core study.
- •12. Any condition or circumstances which, in the opinion of the
- •investigator, may make a subject unlikely or unable to complete the
- •study or comply with study procedures and requirements.
研究者
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