A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis
详细描述
Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
- •Active disease at Screening
- •Stable dose of methotrexate between 10-25 mg/week oral or parenteral
排除标准
- •A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
- •A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides
研究组 & 干预措施
CP-195,543
CP-195,543 and Celecoxib dual therapy.
干预措施: CP-195,543 (Drug)
Celecoxib
Celecoxib with placebo therapy.
干预措施: celecoxib (Drug)
Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Week 12
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
次要结局
- Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8(Week 1, 2, 4, 8)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 1, 2, 4, 8, 12)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 1, 2, 4, 8, 12)
- Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
- Number of Participants Who Withdrew From Study Due to Lack of Efficacy(Baseline up to Week 12)
- Time to Withdrawal Due to Lack of Efficacy(Baseline up to Week 12)
- Number of Participants With Clinical Laboratory Abnormalities(Baseline up to Week 13)