A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.
This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open Label Run-In: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care.
干预措施: etanercept pre-filled syringe subcutaneous injection (Drug)
Open Label Run-In: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care.
干预措施: Oral methotrexate (Drug)
Open Label Run-In: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care.
干预措施: Folic acid (non-investigational product) (Dietary Supplement)
Double-Blind Treatment: Methotrexate Monotherapy
Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: etanercept pre-filled syringe subcutaneous injection (Drug)
Double-Blind Treatment: Methotrexate Monotherapy
Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Oral methotrexate (Drug)
Double-Blind Treatment: Methotrexate Monotherapy
Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Placebo for etanercept subcutaneous injection (Drug)
Double-Blind Treatment: Methotrexate Monotherapy
Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Folic acid (non-investigational product) (Dietary Supplement)
Double-Blind Treatment: Etanercept Monotherapy
Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: etanercept pre-filled syringe subcutaneous injection (Drug)
Double-Blind Treatment: Etanercept Monotherapy
Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Oral methotrexate (Drug)
Double-Blind Treatment: Etanercept Monotherapy
Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Placebo for methotrexate (Drug)
Double-Blind Treatment: Etanercept Monotherapy
Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).
干预措施: Folic acid (non-investigational product) (Dietary Supplement)
Double-Blind Treatment: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will continue on the assigned treatments (as rescue treatment).
干预措施: etanercept pre-filled syringe subcutaneous injection (Drug)
Double-Blind Treatment: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will continue on the assigned treatments (as rescue treatment).
干预措施: Oral methotrexate (Drug)
Double-Blind Treatment: Etanercept plus Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening will continue on the assigned treatments (as rescue treatment).
干预措施: Folic acid (non-investigational product) (Dietary Supplement)
结局指标
主要结局
Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy
时间窗: Week 48
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
次要结局
- SDAI Score at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Percentage of Participants With Disease Worsening(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Change From Baseline in SDAI Score at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Change From Baseline in CDAI at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy(Week 48)
- Change From Baseline in DAS28-CRP at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Change From Baseline in DAS28-ESR at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Clinical Disease Activity Index (CDAI) at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Percentage of Participants With Boolean Remission at All Measured Timepoints(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48(Week 48)
- Time to Disease Worsening(up to Week 48)
- Time to Recapture SDAI Remission After Starting Rescue Treatment(Between rescue and remission or Week 48, whichever comes first.)