EUCTR2016-001496-75-PL进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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) Active RA disease as defined by: a TJC of = 6 (out of 68), an SJC of = 6 (out of 66) at Screening and Day 1
- •2) Inadequate response to treatment with oral or parenteral MTX 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks at a stable dose (defined as no change in prescription) prior to the first dose of study drug
- •3) Subjects must be receiving a folic or folinic acid supplementation at a stable dose. Subjects who are not taking folic or folinic acid at Screening should be initiated on an adequate dose of folic acid (>5 mg/week total dose or as per local practice) or equivalent and maintained throughout the study.
- •4) Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if the dose is stable (defined as no change in prescription) for at least 28 days prior to the first dose of study drug
- •5) NSAIDs or other analgesics (including aspirin = 100 mg daily) are allowed if doses are stable (defined as no change in prescription) for at least 14 days prior to the first dose of study drug; PRN use for other indications is allowed.
- •6) No evidence of active or latent TB as demonstrated by a negative QuantiFERON® TB-Gold In-Tube test at Screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the subject will be excluded from the study. Any prior history of active or latent TB (regardless of treatment) is exclusionary.
- •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) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1) Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at Screening
- •2) Prior treatment with any commercially available or investigational SYK inhibitor
- •3) Concurrent treatment at Screening with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in Section 5.7)
- •4) Concurrent treatment at Screening with any bDMARD (prior bDMARD treatment allowed if appropriate wash out as
- •defined in Section 5.7). Prior failure to treatment with bDMARDs is not an exclusion criterion.
- •5) QT interval corrected for heart rate using the Fridericia formula (QTcF) > 450 msec determined by the average of values at the Screening visit
- •6) History of any major bleeding event defined as Grade 3 severity and above (as defined by modified the Common
- •Terminology Criteria for Adverse Events [CTCAE] 4.03 [Appendix 4]) within the last year or personal or family history of bleeding disorder
- •Current use of chronic anticoagulant, not including daily aspirin for cardiac prophylaxis
- •7) Treatment with moderate or strong CYP3A inducers or inhibitors within 2 weeks prior to the first dose of study drug (examples are provided in Section 5.7)
研究者
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