EUCTR2012-000439-17-GB进行中（未招募）不适用
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis
Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck)0 个研究点目标入组 342 人开始时间: 2012年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 342
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
- •Subject must be =18 years of age on the day of signing the informed consent.
- •RA diagnosis and disease activity:
- •Subject has a diagnosis of RA for at least 6 months prior to screening.
- •Subject has active RA as defined by the presence of 6 swollen joints (of 66 joint count) AND 6 tender joints (of 68 joint count) at screening (Visit 1) and baseline (Visit 2).
- •Subject has a C-reactive protein (CRP) blood level > 0.9 mg/dL from the central reference laboratory at screening.
- •Subject is anti-cyclic citrullinated antibody positive and/or rheumatoid factor positive at screening.
- •Subject is ACR functional Class I, II, or III.
- •Subjects has received MTX for a minimum of 3 months with a regionally appropriate stable weekly dose (15-25 mg/wk for regions outside of Asia, 6–25 mg/week for Asia) for at least 4 wks prior to entering study.
- •Subject must meet all Tuberculosis (TB) screening criteria: No history of untreated latent or active TB prior to baseline; Has no signs or symptoms suggestive of active TB; Has had no recent close contact with a person with active TB (if there has been contact, patient will be evaluated and receive appropriate treatment for latent TB at least 4 weeks prior to first dose of study medication; Within 4 weeks prior to first administration of study medication, has negative diagnostic TB test result ; has a chest radiograph within two months prior to screening with no evidence of current or old inactive TB
- •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 419
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Subject has inflammatory disease other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
- •Previous exposure to fostamatinib or other splenic tyrosine kinase (SYK) inhibitors.
- •Previous exposure to TNF-alpha targeted therapy or any biological agents for RA.
- •Subject has received any treatment listed below more recently than the indicated washout period prior to Screening.
- •Prohibited Medications, Supplements, and Other SubstancesWashout Period Prior to Screening
- •Disease modifying anti-rheumatic drugs such as but not limited to (not including cytotoxic agents):
- •Leflunomide, cyclosporine, mycophenolate mofetil, azathioprine, corticosteroids (parenteral, intra-articular), sulfasalazine, hydroxychloroquine30 days (8 weeks for leflunomide unless subject undergoes standard cholestyramine or activated charcoal washout)
- •Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents3 months
- •Live vaccinations1 month
- •Investigational medications30 days or 5 half lives of the investigational agent whichever is longer
- •Bacille Calmette-Guerin (BCG) vaccination1 month
- •Subject has sustained uncontrolled hypertension or uncontrolled diabetes
- •Subject has been hospitalised due to an acute cardiovascular event, CV illness or CV surgery within 6 months of screening
- •Subject is taking concomitant doses of statins exceeding the following: atorvastatin 40mg/day; fluvastatin 40mg/day, pravastatin 40mg/day, rosuvastatin 20mg/day and simvastatin 20mg/day, pitavastatin 2mg/day (if lower doses of statins are approved in an individual country, subjects taking concomitant statins above half the maximum approved dose are excluded)
研究者
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