A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH 797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 305
- 试验地点
- 48
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12
研究概览
简要总结
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA and has failed at least 1 DMARD therapy
排除标准
- •Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.
研究组 & 干预措施
1
干预措施: placebo (Drug)
2
干预措施: PH-797804 (Drug)
3
干预措施: PH-797804 (Drug)
4
干预措施: PH-797804 (Drug)
5
干预措施: PH-797804 (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12
时间窗: Week 12
ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.
次要结局
- Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16(Weeks 1, 2, 4, 8, 16)
- Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16(Weeks 1, 2, 4, 8, 12 and 16)
- Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16(Weeks 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Weeks 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Weeks 1, 2, 4, 8, 12 and 16)
- Number of Participants Who Withdrew From Study Due to Lack of Efficacy(Baseline up to Week 16)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Weeks 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Weeks 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 16)
- Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8 and 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12(Baseline, Weeks 4, 12)
- Number of Participants With Laboratory Abnormalities(Baseline up to Week 16)
- Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State(Predose)
- Number of Participants With Concomitant Medications(Baseline up to Week 16)
- Number of Participants With Clinically Significant Vital Signs Abnormalities(Baseline up to Week 16)
- Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters(Baseline up to Week 16)
- Number of Participants With Electrocardiogram (ECG) Abnormalities(Baseline up to Week 16)
- Number of Participants With Clinically Significant Physical Examination Abnormalities(Baseline up to Week 16)