NL-OMON44070撤回3 期
A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) - M14-465 (MTX-IR Structure)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- AbbVie B.V.
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult male or female, at least 18 years old.;2. Diagnosis of RA for * 3 months.;3. Subjects must have been on oral or parenteral MTX therapy * 3 months and on a stable prescription
- •of 15 to 25 mg/week (or * 10 mg/week in subjects intolerant of MTX at doses * 15 mg/week) for
- •* 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary
- •supplement of folic acid or folinic acid throughout the study participation.;4. Subject meets both of the following disease activity criteria:
- •a. * 6 swollen joints (based on 66 joint counts) and * 6 tender joints (based on 68 joint counts) at
- •Screening and Baseline Visits; and
- •b. hsCRP * 5 mg/L (central lab, ULN 2.87 mg/L) at Screening Visit.;5. Subject has at least one of the following at Screening:
- •a. * 3 bone erosions on x-ray; or
- •b. * 1 bone erosion and a positive rheumatoid factor; or
- •c. * 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibody.;6. Subjects with prior exposure to only one bDMARD (except ADA) may be enrolled (up to 20% of
- •total study population) if they have documented evidence of intolerance to the bDMARD or limited
- •exposure (< 3 months).;7. Except for MTX, subject must have discontinued all csDMARDs. The washout period for
- •csDMARDs prior to the first dose of study is specified below or should be at least five times the
- •mean terminal elimination half-life of a drug:
- •*** 4 weeks prior to first dose of study drug for minocycline, penicillamine, sulfasalazine,
- •hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide,
- •tacrolimus, cyclosporine, mycophenolate;
- •*** 8 weeks prior to first dose of study drug for leflunomide if no elimination procedure was
- •followed, or adhere to an elimination procedure (i.e., 11 days with colestyramine, or 30 days
- •washout with activated charcoal or as per local label).
排除标准
- •1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).;2. Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.;3. History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
研究者
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