Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 84
- 试验地点
- 33
- 主要终点
- Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24
研究概览
简要总结
Primary Objective:
To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.
Secondary Objectives:
- To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy.
- To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
- To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
- To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
详细描述
The study duration per participant was approximately 32 weeks, with up to 4-week screening, 24 weeks treatment period, and 2-4 weeks post-treatment observations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Chloroquine (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: SARILUMAB (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Azathioprine (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Hydroxychloroquine (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Leflunomide (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Methotrexate (Drug)
Sarilumab
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
干预措施: Sulfasalazine (Drug)
结局指标
主要结局
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24
时间窗: Baseline, Week 24
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
次要结局
- Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24(Baseline, Weeks 4, 12 and 24)
- Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24(Weeks 12 and 24)
- Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24(Weeks 12 and 24)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline up to end of study (up to 39.7 weeks))
- Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Number of Swollen Joints at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Number of Tender Joints at Baseline, Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)
- Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24(Baseline, Weeks 4, 12 and 24)