NCT00650455已完成4 期
Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population
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
- 489
- 试验地点
- 1
- 主要终点
- ACR-20 criteria responder
研究概览
简要总结
The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
- •The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)
排除标准
- •A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from the study
研究组 & 干预措施
Arm 2
Active Comparator
干预措施: naproxen (Drug)
Arm 3
Placebo Comparator
干预措施: placebo (Drug)
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
结局指标
主要结局
ACR-20 criteria responder
时间窗: Week 12
次要结局
- Patient's Global Assessment of Disease Activity(Screening, Baseline, Week 1, Week 6, and Week 12)
- Adverse events(Baseline, Week 1, Week 6, and Week 12)
- tender joint count(Screening, Baseline, Week 1, Week 6, and Week 12)
- One-Week Severity of Dyspepsia Assessment(Baseline, Week 1, and Week 12)
- physical examinations(Screening and Week 12)
- Patient's assessment of arthritis pain (VAS)(Screening, Baseline, Week 1, Week 6, and Week 12)
- Physician's Global Assessment of Disease Activity(Screening, Baseline, Week 1, Week 6, and Week 12)
- swollen joint count(Screening, Baseline, Week 1, Week 6, and Week 12)
- Short Form-36 Acute Health Survey(Baseline, Week 1, Week 6, and Week 12)
- laboratory tests(Screening, Baseline, Week 1, Week 6, and Week 12)
- Duration of morning stiffness(Screening, Baseline, Week 1, Week 6, and Week 12)
- vital signs(Screening, Baseline, Week 1, Week 6, and Week 12)
- Patient Treatment Satisfaction Scale(Week 1 and Week 6)
- Incidence and time to withdrawal due to insufficient clinical response(Study endpoint)
- Average rescue medication usage per day(Study endpoint)
- ACR-N(Study endpoint)
- Health Assessment Questionnaire (HAQ) Disability Index(Screening, Baseline, Week 1, Week 6, and Week 12)
- C-reactive protein(Screening, Baseline, Week 1, Week 6, and Week 12)
研究者
研究点 (1)
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