An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 141
- 主要终点
- Change From Baseline in Modified Total Sharp Score (TSS) at Week 52
研究概览
简要总结
To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.
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
- None
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
- •Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
- •Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
- •Have received MTX as stable dose for 28 days prior to the screening visit.
排除标准
- •Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
- •Receipt of any DMARD, other than MTX, within 28 days before screening.
研究组 & 干预措施
Usual care
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
干预措施: methotrexate (Drug)
ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
干预措施: etanercept (EnbrelTM) (Drug)
ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
干预措施: methotrexate (Drug)
结局指标
主要结局
Change From Baseline in Modified Total Sharp Score (TSS) at Week 52
时间窗: Baseline, Week 52
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
次要结局
- Change From Baseline in Erosions at Week 52(Baseline, Week 52)
- Change From Baseline in Joint Space Narrowing at Week 52(Baseline, Week 52)
- Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52(Baseline, Week 52, Last observation carried forward (LOCF))
- Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)(Baseline, Week 12, Week 24, and Week 52)
- Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)(Week 4, Week 12, Week 24, Week 40, Week 52)
- Percentage of Participants Achieving Remission (DAS28 <2.60)(Week 12, Week 24, and Week 52)
- Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)(Week 12, Week 24, and Week 52)
- Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response(Week 12, Week 24, and Week 52)
- Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria(Week 12, Week 24, Week 52)
- Percentage of Participants With American College of Rheumatology 20% (ACR20) Response(Week 12, Week 24, Week 52)
- Percentage of Participants With American College of Rheumatology 50% (ACR50) Response(Week 12, Week 24, Week 52)
- Percentage of Participants With American College of Rheumatology 70% (ACR70) Response(Week 12, Week 24, Week 52)
- Percentage of Participants With American College of Rheumatology 90% (ACR90) Response(Week 12, Week 24, Week 52)
- Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period(Week 4, Week 12, Week 24, Week 40, Week 52)
- Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)(Week 12, Week 52)
- Health Related Quality of Life: EuroQol-5D Health Index(Baseline, Week 12, Week 24, and Week 52)
- Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)(Baseline, Week 12, Week 24, and Week 52)