EUCTR2011-003538-16-GR进行中（未招募）不适用
A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 522
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
- •Diagnosis of rheumatoid arthritis =6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
- •ACR Class I-III functional status, based on 1991 revised criteria
- •Anti-TNF therapy failures, defined by the investigator as patients with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation:
- •TNF-blockers may include, but are not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab.
- •Moderate-to-severely active rheumatoid arthritis.
- •Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening:
- •Methotrexate – 6 to 25 mg/wk orally or intramuscular
- •Leflunomide – 10 to 20 mg orally daily
- •Sulfasalazine – 1000 to 3000 mg orally daily.
- •Hydroxychloroquine - 200 to 400 mg orally daily.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •Patients <18 years of age.
- •Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- •History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- •Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty’s syndrome.
- •Treatment with anti-TNF agents, as follows:
- •Within 28 days prior to the baseline visit – etanercept
- •Within 42 days prior to the baseline visit – infliximab, adalimumab, golimumab, certolizumab pegol
- •Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms:
- •Within 28 days prior to the randomization (baseline) visit – anakinra
- •Within 42 days prior to the randomization (baseline) visit – abatacept
- •Within 6 months prior to the randomization (baseline) visit – any cell depleting agents including but not limited to rituximab without a normal lymphocyte and CD 19+ lymphocyte count.
- •Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline.
- •Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit.
- •Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
- •Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm.
- •Prior treatment with a Janus kinase inhibitor (such as tofacitinib).
- •New treatment or dose-adjustment to ongoing statin medication within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization.
- •Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever is longer.
- •History of alcohol or drug abuse within 5 years prior to the screening visit.
- •Patients with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders are also excluded.
- •Patients with active tuberculosis or latent tuberculosis infection.
研究者
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