NCT01579006已完成不适用
A Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)
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
- 184
- 主要终点
- Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
研究概览
简要总结
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.
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 patients, >/= 18 years of age
- •Moderate to severe rheumatoid arthritis
- •Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
- •Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit
排除标准
- •RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
- •Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- •Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
研究组 & 干预措施
Cohort
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
时间窗: 6 months
Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation
时间窗: 5-6 months
次要结局
- Percentage of Participants With Systemic Manifestations of RA at Baseline(Baseline)
- Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study(Prior to study start (8 weeks) and Baseline up to 6 months)
- Percentage of Participants With Reason for DMARD Withdrawal(Up to 6 months)
- Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study(Prior to study start (8 weeks))
- Percentage of Participants With Type of Previous Biologic RA Treatments(Up to 6 months)
- Duration of Previous Biologic RA Treatments(Up to 6 months)
- Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments(Up to 6 months)
- Percentage of Participants With Dose Modifications(6 months)
- Percentage of Participants With Reasons for Dose Modification(6 months)
- Mean Dose at 6 Months(6 months)
- Mean Number of Dose Modifications at 6 Months(6 months)
- Mean Dosing Interval of Treatment at 6 Months(6 months)
- Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy(6 months)
- Time to Restoration of Initial Dosing Regimen(6 months)
- Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician(6 months)
- Percentage of Participants on TCZ Monotherapy(Up to 6 months)
- Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6(Baseline, 6 months)
- Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6(Baseline, 6 months)
- Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6(Baseline, 6 months)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6(6 months)
- Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6(Baseline, 6 months)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6(Baseline, 6 months)
- Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6(6 months)
- Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6(6 months)
- Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6(6 months)
- Change From Baseline in CRP at Month 6(Baseline, 6 months)
- Change From Baseline in ESR at Month 6(Baseline, 6 months)
- Change From Baseline in PhGH at Month 6(Baseline, 6 months)
- Change From Baseline in PGH of Disease Activity at Month 6(Baseline, 6 months)
- Change From Baseline in HAQ-DI at Month 6(Baseline, 6 months)
- Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6(Baseline, 6 months)
- Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6(Baseline, 6 months)
- Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6(Administration 1 (Baseline), 6 months)
- Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6(Baseline, 6 months)
研究者
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