A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 70
- 试验地点
- 30
- 主要终点
- Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
研究概览
简要总结
This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-06651600
Study Drug
干预措施: PF-06651600 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
时间窗: Baseline, Week 8
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (\<=) 3.3 indicates disease remission, greater than (\>) 3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
次要结局
- Number of Participants With Vital Signs Abnormalities(Baseline up to Week 12)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 12)
- Remission Rate Based on Disease Activity Score (DAS28-4[ESR])(Week 4, 6 and 8)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Number of Participants With Laboratory Abnormalities(Baseline up to Week 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, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6(Baseline, Week 1, 2, 4 and 6)
- Remission Rate Based on Simple Disease Activity Index Score(Week 4, 6 and 8)
- Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])(Week 4, 6 and 8)
- Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])(Week 4, 6 and 8)
- Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])(Week 4, 6 and 8)
- Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)
- Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6 and 8)