NCT02187055已完成4 期
A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,152
- 试验地点
- 211
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
研究概览
简要总结
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
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
- •Have moderate to severe rheumatoid arthritis
- •On methotrexate but inadequately controlled
- •Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
- •Subjects must use contraception
排除标准
- •Subjects who have been previously treated with adalimumab or Tofacitinib
- •Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •Subjects with specific laboratory test abnormalities
- •Subjects with specific types of infections
研究组 & 干预措施
Tofacitinib 5 mg twice daily with methotrexate
Experimental
干预措施: Tofacitinib with methotrexate (Drug)
Tofacitinib 5 mg twice daily monotherapy
Experimental
干预措施: Tofacitinib without methotrexate (Drug)
Adalimumab with methotrexate
Active Comparator
干预措施: Adalimumab with methotrexate (Biological)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
时间窗: Month 6
ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.
次要结局
- Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6(Month 6)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6(Month 6)
- Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6(Month 6)
- Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6(Month 6)
- Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6(Month 6)
- Percentage of Participants Achieving SDAI ≤3.3 at Month 6(Month 6)
- Percentage of Participants Achieving CDAI ≤10 at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6(Month 6)
- Percentage of Participants Achieving CDAI ≤2.8 at Month 6(Month 6)
- Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6(Month 6)
- Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6(Month 6)
- Percentage of Participants Achieving SDAI ≤11 at Month 6(Month 6)
- Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6(Month 6)
- Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6(Month 6)
- Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6(Month 6)
- Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6(Month 6)
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6(Month 6)
- Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6(Month 6)
- Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6(Month 6)
- Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6(Month 6)
- Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6(Month 6)
- Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6(Month 6)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6(Month 6)
研究者
研究点 (211)
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