JPRN-jRCT2080223027已完成3 期
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Rheumatoid arthritis (RA) diagnosis less than 6 months
- •CRP greater than 3 mg/L or Erythrocyte Sedimentation Rate (ESR) not less than 28 mm/h
- •At least 3 swollen and 3 tender joints
- •Anti-citrullinated protein antibodies (ACPA) positive
排除标准
- •At risk for tuberculosis
- •Have acute infection
- •Have chronic or recurrent bacterial or serious latent viral infection
- •History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
- •Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
研究者
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3 期
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate NaiveRheumatoid Arthritis10003816NL-OMON43711Bristol-Myers Squibb24
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