A Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of BG00012 when given with methotrexate to subjects with active rheumatoid arthritis who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy.

Biogen Idec, Inc0 个研究点目标入组 150 人开始时间: 2008年12月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Written informed consent
•- Diagnosis of adult onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Functional Class I – III)(Section22, Appendix A) for at least 6 months prior to Day 0.
•- Must have been treated with, and be tolerating, methotrexate for at least 3 months immediately prior to Day 0. The dose of mthotrexate must be stable for at least 4 weeks prior to Day 0.
•- All subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.

•Medical History
•1. Subjects with a history of malignant disease, including solid tumors and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
•2. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
•3. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson’s disease, cerebral palsy, diabetic neuropathy).
•4. Known active bacterial, viral, fungal, mycobacterial, opportunistic infection or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of Day 0.
•5. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
•Treatment History
•6. Other clinical issues or laboratory results that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

发起方