NCT01705730已完成不适用
Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 17
- 主要终点
- Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
研究概览
简要总结
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult participants, >/= 18 years of age
- •Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- •Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- •Concomitant treatment with NSAIDs and/or corticosteroids is allowed
排除标准
- •Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- •Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- •Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
- •Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
研究组 & 干预措施
Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
干预措施: tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
时间窗: Month 6 after treatment initiation
次要结局
- Percentage of Participants With Systemic Manifestations of RA at Baseline(Baseline)
- Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response(Baseline)
- Number of Participants With Inadequate Response to Other Biologics(Baseline)
- Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)(Month 6)
- Percentage of Participants Who Had DMARDs During Study(Month 6)
- Number of Participants With Dose Reductions(6 months)
- Number of Participants With Starting Tocilizumab After Failing DMARDs(Baseline)
- Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents(Baseline)
- Number of Dose Modifications Per Participant at Month 6(Month 6)
- Mean Dosing Interval Per Participant at Month 6(Month 6)
- Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy(Month 6)
- Time for Restoration of Initial Dosing Regimen(Month 6)
- Time to Reduction/Withdrawal of Corticosteroids(Month 6)
- Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen(Month 6)
- Number of Participants Who Were Not Adhering to Recommended Management of AEs(Month 6)
- Percentage of Participants Still on Tocilizumab Monotherapy at Month 6(Month 6)
- Percentage of Participants With Reason for Choice of Monotherapy at Baseline(Baseline)
- Tender Joint Count (TJC)(Baseline, Month 3, 6)
- Swollen Joint Count (SJC)(Baseline, Month 3, 6)
- Change From Baseline in VAS-Fatigue at Month 3 and Month 6(Baseline, Month 3, 6)
- Percentage of Participants With Disease Activity Score-28 (DAS28)(Baseline, Month 3, 6)
- Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6(Month 3, 6)
- Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6(Month 3, 6)
- Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response(Baseline, Month 3, 6)
- Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response(Baseline, Month 3, 6)
- Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6(Baseline, Month 3, 6)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6(Baseline, Month 3, 6)
- C-reactive Protein (CRP]) Level(Baseline, Month 3, 6)
- Erythrocyte Sedimentation Rate (ESR) Level(Baseline, Month 3, 6)
- Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6(Baseline, Month 3, 6)
- Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)(Month 6)
- Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6(Baseline, Month 3, 6)
- Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6(Baseline, Month 3, 6)
- Percentage of Participants With AEs Leading to Dose Modifications(Month 6)
研究者
研究点 (17)
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