A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
研究概览
简要总结
This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.
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
- •Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.
排除标准
- •Any prior use of rituximab or other B cell depleting agents.
- •Any significant health problem other than rheumatoid arthritis
- •Clinically significant laboratory abnormalities
研究组 & 干预措施
Arm 1
Consists of Arms 1a and 1b
干预措施: TRU-015 (Drug)
Arm 1
Consists of Arms 1a and 1b
干预措施: Methylprednisolone (Drug)
Arm 1
Consists of Arms 1a and 1b
干预措施: Prednisone (Drug)
Arm 2
Consists of Arms 2a and 2b
干预措施: TRU-015 (Drug)
Arm 2
Consists of Arms 2a and 2b
干预措施: Methylprednisolone (Drug)
Arm 2
Consists of Arms 2a and 2b
干预措施: Prednisone (Drug)
Arm 3
Consists of Arms 3a and 3b.
干预措施: TRU-015 (Drug)
Arm 3
Consists of Arms 3a and 3b.
干预措施: Methylprednisolone (Drug)
Arm 3
Consists of Arms 3a and 3b.
干预措施: Prednisone (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
时间窗: Week 24
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% 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 \[HAQ-DI\]); and C-Reactive Protein (CRP).
次要结局
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Number of Tender Joints(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Number of Swollen Joints(Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Duration of Morning Stiffness(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Visual Analogue Scale for Pain (VAS-pain)(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Physician Global Assessment (PGA) of Disease Activity(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Patient Global Assessment (PtGA) of Disease Activity(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- General Health Visual Analog Scale (VAS)(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Disease Activity Score Based on 28-joints Count (DAS28)(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12, 24, 36, 52)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Baseline, Week 12, 24, 36, 52)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)(Baseline, Week 12, 24, 36, 52)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score(Baseline, Week 12, 24, 36, 52)
- Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score(Baseline, Week 12, 24, 36, 52)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28(Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)