NCT00858780已完成4 期
Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Percentage of Participant Who Were Non-Failures
研究概览
简要总结
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.
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
- •Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
- •Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
- •Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
研究组 & 干预措施
1
Active Comparator
50mg once weekly + methotrexate
干预措施: Etanercept (Drug)
2
Active Comparator
25mg once weekly + methotrexate
干预措施: Etanercept (Drug)
3
Placebo Comparator
once weekly + methotrexate
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participant Who Were Non-Failures
时间窗: Week 48
A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.
次要结局
- Time to Treatment Failure (TTF)(Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48))
- Percentage of Participants With Remission or Low Disease Activity (LDA)(Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State(Randomization (Week 0) up to Week 48)
- Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization(Randomization (Week 0))
- Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Participant General Health Visual Analog Scale (VAS) at Randomization(Randomization (Week 0))
- Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Participant Pain Visual Analog Scale (VAS) at Randomization(Randomization (Week 0))
- Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48(Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48)
- Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48(Randomization (Week 0), Week 48)
- Magnetic Resonance Imaging (MRI) Findings at Randomization(Randomization (Week 0))
- Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12(Randomization (Week 0), Week 12)
- Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12(Randomization (Week 0), Week 12)
- Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization(Randomization (Week 0) up to Week 48)
研究者
研究点 (1)
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