EUCTR2012-004342-14-LT进行中（未招募）不适用
A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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.Subjects must have completed the assigned study drug treatment phase of a previous VX 509 study (e.g., Study 103).
- •2.Subjects must voluntarily sign and date the Study 104 informed consent document.
- •3.Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature
- •2.History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
- •3.History of cancer, except squamous or basal cell cancers of the skin or in situ cancer of the cervix.
- •4.History of hematologic disorders including neutropenia and thrombocytopenia other than Felty syndrome.
- •5.History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
- •6.Acute or chronic active infection requiring systemic antimicrobial treatment with the exception of onychomycosis receiving antifungal medication or acne and rosacea receiving low-dose antibiotics.
- •7.History of previous osteomyelitis, infected joint, or joint prosthesis.
- •8.Subjects who are at high risk of developing an infection due to a compromised immune system including poorly controlled diabetes.
研究者
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