PER-033-13未知未知
A RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF SARILUMAB ADDED TO NON-BIOLOGIC DMARD THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO ARE INADEQUATE RESPONDERS TO OR INTOLERANT OF TNF-α ANTAGONISTS
Sanofi Aventis Recherche & Development,0 个研究点目标入组 67 人开始时间: 2014年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 67
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 100（—）
- 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
- •Patients who, per Investigator assessment, have had an inadequate response to at least one TNF antagonist, after being treated for at least 3 consecutive months, any time before screening or patients intolerant to at least 1 TNF antagonist, resulting in discontinuation
- •- TNF-antagonists may include etanercept, infliximab,
- •adalimumab, golimumab and/or certolizumab pegol
- •Active disease defined as:
- •- at least 6 of 66 swollen joints and 8 of 68 tender at screening and baseline visits, and
- •- hs-CRP ≥8 mg/L at screening
- •Continuous treatment with one or a combination of non-biologic DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 consecutive weeks prior to randomization and on a stable dose(s) for at least 6 consecutive weeks prior to screening.
- •Patients who have signed a written informed consent prior to performance of any study-related procedures.
排除标准
- •Age <18 years
- •Treatment with TNF antagonists as follows:
- •- Etanercept: Within 28 days prior to randomization
- •- Infliximab, adalimumab, golimumab and certolizumab pegol: Within 42 days prior to randomization
- •Treatment with RA-directed biologic agents with non-TNF-α antagonist mechanisms as follows:
- •- Anakinra: Within 28 days prior to randomization
- •- Abatacept: Within 42 days prior to randomization
- •- Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count are normalized, whichever is longer
- •Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab
- •Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to randomization
- •Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to randomization
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