A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Change From Baseline in Swollen Joint Count
研究概览
简要总结
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
- •Other criteria also apply
排除标准
- •Other major illnesses
- •Past history of certain other disorders
- •Certain prohibited medications
研究组 & 干预措施
MK-0873
MK-0873 1.25 mg twice daily for 12 weeks
干预措施: MK-0873 (Drug)
结局指标
主要结局
Change From Baseline in Swollen Joint Count
时间窗: Baseline and the average of Treatment Weeks 8, 10 and 12
Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.
次要结局
- Patient's Assessment of Pain(Treatment Week 12)
- Percentage of Participants With American College of Rheumatology 20% Response [ACR20](Baseline and the average of Treatment Weeks 8, 10 and 12)
- Change From Baseline in Tender Joint Count(Baseline and the average of Treatment Weeks 8, 10 and 12)
- Patient Global Assessment of Disease Activity(The average of Treatment Weeks 8, 10 and 12)
- Investigator Global Assessment of Disease Activity(Treatment Week 12)
- Patient Global Assessment of Response to Therapy(Treatment Week 12)
- Health Assessment Questionnaire Disability Index(The average of Treatment Weeks 8, 10 and 12)
- Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein(Baseline and the average of Treatment Weeks 8, 10 and 12)