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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 994
- 试验地点
- 91
- 主要终点
- Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
研究概览
简要总结
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.
详细描述
Subcutaneous (SC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis (RA) diagnosis less than 6 months
- •CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 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)
研究组 & 干预措施
Combination Therapy: Abatacept + Methotrexate
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
干预措施: Abatacept (Drug)
Combination Therapy: Abatacept + Methotrexate
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
干预措施: Methotrexate (Drug)
Methotrexate treatment
Methotrexate at least 15mg per week tablet or capsule orally
干预措施: Methotrexate (Drug)
Abatacept Placebo
Placebo for Abatacept subcutaneous injection once per week
干预措施: Abatacept Placebo (Other)
Methotrexate Placebo
Placebo to match Methotrexate capsule orally once per week
干预措施: Methotrexate Placebo (Other)
结局指标
主要结局
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
时间窗: Week 24
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
次要结局
- Percentage of Participants in SDAI Remission at Week 52(Week 52)
- Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52(Week 52)
- Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24(Week 24)
- Percentage of Participants in Boolean Remission at Week 52(Week 52)