EUCTR2012-003655-11-BE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）
- 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
- •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. 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- •1-Subjects who had been prematurely withdrawn from one of the 2 core studies
- •(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 use of
- •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 judgment.
- •4. Subjects who require immunization with live/live attenuated vaccine.
- •5. Subjects with diagnosis since the inclusion to GLPG0634-CL-203 or GLPG0634-CL-204 core studies 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 and GLPG0634-CL-204 core studies.
- •7. Subjects with symptoms suggestive of GI tract ulceration and/or active diverticulitis since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies.
- •8. Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies.
- •9. Subjects with symptoms suggestive of malignancy since the inclusion to GLPG0634-CL-203 and GLPG0634-CL-204 core studies.
- •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 and GLPG0634-CL-204 core studies.
- •11. History of drug and alcohol abuse since the inclusion to GLPG0634-CL-203 and GLPG0634–CL-204 core studies.
- •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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