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临床试验/NCT01039688
NCT01039688已完成3 期

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Pfizer173 个研究点 分布在 5 个国家目标入组 956 人开始时间: 2010年1月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
956
试验地点
173
主要终点
Modified Total Sharp Score (mTSS) at Month 6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

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 99 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
  • •Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
  • •Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

排除标准

  • •Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
  • •History of any other rheumatic autoimmune disease other than Sjogren's syndrome
  • •No malignancy or history of malignancy
  • •History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
  • •No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

研究组 & 干预措施

methotrexate

Active Comparator

干预措施: Disease-modifying antirheumatic drug (Drug)

5 mg BID CP-690,550

Experimental

干预措施: CP-690,550 (Drug)

10 mg BID CP-690,550

Experimental

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Modified Total Sharp Score (mTSS) at Month 6

时间窗: Month 6

mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).

Change From Baseline at Month 6 in mTSS

时间窗: Month 6

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6

时间窗: Month 6

ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).

Absolute Blood Pressure (BP) Values (mmHg)

时间窗: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

Change From Baseline in BP Values (mmHg)

时间窗: Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

次要结局

  • mTSS Score at Baseline, Months 12 and 24(Baseline, Months 12 and 24)
  • Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24(Months 6, 12, and 24)
  • Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24(Months 6, 12, and 24)
  • Erosion Scores(Baseline, Months 6, 12, and 24)
  • Percentage of Participants Achieving an ACR50 Response(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Tender Joints Count (TJC)(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in mTSS Score at Months 12 and 24(Months 12 and 24)
  • Change From Baseline in TJC(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • JSN Scores(Baseline, Months 6, 12, and 24)
  • Change From Baseline in Erosion Scores(Months 6, 12, and 24)
  • Change From Baseline in JSN Scores(Months 6, 12, and 24)
  • Percentage of Participants Achieving an ACR70 Response(Months 1, 2, 3, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants Achieving an ACR20 Response(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in DAS28-3(CRP)(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Swollen Joints Count (SJC)(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in SJC(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in Physician Global Assessment of Arthritis(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in Patient Global Assessment of Arthritis(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Patient Assessment of Arthritis Pain(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Physician Global Assessment of Arthritis(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in CRP(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in Patient Assessment of Arthritis Pain(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Patient Global Assessment of Arthritis(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • C-Reactive Protein(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in DAS28-4(ESR)(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-3(CRP) ≤3.2(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-4(ESR) ≤3.2(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-3(CRP) <2.6(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-4(ESR) <2.6(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits(Months 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in HAQ-DI Score(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With at Least 0.5 Improvement in HAQ-DI(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Short Form 36 (SF-36) Mental Component Score(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With an ACR70 Response Sustained at Least 6 Months(Months 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits(Months 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits(Months 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits(Months 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits(Months 3, 6, 9, 12, 15, 18, 21, and 24)
  • SF-36 Domain Scores(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • SF-36 Physical Component Score(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in SF-36 Physical Component Score(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in SF-36 Domain Scores(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Work Limitation Questionnaire (WLQ) Score(Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in WLQ Scores(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • WLQ Work Loss Index Score(Baseline and Months 3, 6, and 12)
  • Change From Baseline in WLQ Work Loss Index Score(Months 3, 6, 12, 15, 18, 21, and 24)
  • Change From Baseline in SF-36 Mental Component Score(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score(Baseline and Months 3, 6, 12, 18, and 24)
  • Change From Baseline in EQ-5D Health State Profile Utility Score(Months 3, 6, 12, 18, and 24)
  • Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6(Baseline and Months 3 and 6)
  • Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24(Months 12, 18, and 24)
  • Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6(Baseline and Months 3 and 6)
  • Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6(Baseline and Months 3 and 6)
  • Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6(Baseline and Months 3 and 6)
  • Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU(Baseline, Months 3, 6, 12, 18, and 24)
  • Change From Baseline in Work Productivity and HCRU at Months 3 and 6(Months 3 and 6)
  • Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6(Months 3 and 6)
  • Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6(Months 3 and 6)
  • Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6(Months 3 and 6)
  • Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24(Months 12, 18, and 24)
  • Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU(Months 3, 6, 12, 18, and 24)
  • Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3(Baseline and Months 1, 2, and 3)
  • Percentage of Participants With Optimal Sleep Assessed Using MOS-SS(Months 1, 2, 3, 6, 12, 18, and 24)
  • Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24(Months 6, 12, 18, and 24)
  • Change From Baseline in MOS-SS at Months 1, 2, and 3(Months 1, 2, and 3)
  • Change From Baseline in MOS-SS at Months 6, 12, 18, and 24(Months 6, 12, 18, and 24)
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline and Months 1, 2, 3, 6, 12, 18, and 24)
  • Change From Baseline in FACIT-Fatigue Scale(Months 1, 2, 3, 6, 12, 18, and 24)
  • Change From Baseline in Heart Rate(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)
  • Change From Baseline in Temperature(Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (173)

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