A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 86
- 试验地点
- 41
- 主要终点
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
研究概览
简要总结
This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
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
- •Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
- •On stable dose of methotrexate for at least 6 weeks prior to screening
- •Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
- •Not currently receiving steroid medication
排除标准
- •Pregnant or nursing women
- •Patients that have active infections, TB, HIV and/or Hepatitis B or C
- •Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids
研究组 & 干预措施
PF-04171327 10 mg
干预措施: PF-04171327 10 mg (Drug)
PF-04171327 10 mg
干预措施: Prednisone Placebo (Other)
PF-04171327 25 mg
干预措施: PF-04171327 25 mg (Drug)
PF-04171327 25 mg
干预措施: Prednisone Placebo (Other)
Prednisone
干预措施: Prednisone 5 mg (Drug)
Prednisone
干预措施: Placebo for PF-04171327 (Other)
Placebo
干预措施: Placebo (Other)
Placebo
干预措施: Placebo for PF-04171327 (Other)
结局指标
主要结局
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
时间窗: Baseline, Day 14
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
次要结局
- Change From Baseline in Tender Joints Count at Day 7, 14, 42(Baseline, Day 7, 14, 42)
- Change From Baseline in Swollen Joints Count at Day 7, 14 and 42(Baseline, Day 7, 14, 42)
- Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42(Baseline, Day 7, 14, 42)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14(Baseline, Day 7, 14)
- Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14(Baseline, Day 7, 14)
- Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14(Baseline, Day 7, 14)
- Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14(Baseline, Day 7, 14)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14(Baseline, Day 14 (D14))
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42(Baseline, Day 7, 14, 42)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7(Baseline, Day 7)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14(Day 7, 14)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14(Day 7, 14)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14(Day 7, 14)
- Change From Baseline in Adiponectin Level at Day 7 and 14(Baseline, Day 7 and 14)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Day 45)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities(Baseline up to Day 45)
- Change From Baseline in Body Weight at Day 7 and 14(Baseline, Day 7, 14)
- Number of Participants With Clinically Significant Vital Signs Abnormalities(Baseline up to Day 45)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to Day 45)
- Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14(0, 1, 2, 3 and 4 hours post-dose on Day 7, 14)
- Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate(Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose)
- Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14(Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14)
- Change From Baseline in Neutrophil Counts at Day 1, 7 and 14(Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14)
- Change From Baseline in Eosinophil Counts at Day 1, 7 and 14(Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14)
- Change From Baseline in Osteocalcin Level at Day 1, 7 and 14(Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14)
- Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14(Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14)
- Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14(Baseline, Day 7 and 14)