EUCTR2007-000896-41-ES进行中（未招募）不适用
Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate
Wyeth Pharmaceuticals France0 个研究点目标入组 900 人开始时间: 2007年12月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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. Subject has a diagnosis of RA based on the 1987 American College of Rheumatology (ACR) Revised Criteria for RA.
- •2. Subject is currently receiving an optimal dose of oral MTX once weekly for the treatment of RA, in the opinion of the investigator, but at least 15 mg/week but no more than 25 mg/week and at a stable dose for a minimum of 8 weeks at screening.
- •3. Subject has moderate RA disease activity, as defined by a DAS28 >3.2 and =5.1 at both the screening and baseline visits.
- •4. Subject has a functional status of class I, II, or III as defined by the ACR Revised Criteria.
- •5. Subject is 18 to 70 years of age at the time of consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-a) inhibitors, or other biologic agents.
- •2. Subject has received any DMARD, other than MTX, within 28 days before baseline.
- •3. Subject has had concurrent treatment with more than 1 NSAID at screening.
- •4. Subject has had a dose of an NSAID that has changed within 14 days before screening.
- •5. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 14 days before screening.
- •6. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 28 days before screening.
研究者
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