A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Rheumatoid Arthritis
- 发起方
- Hoffmann-La Roche
- 入组人数
- 1225
- 主要终点
- Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.
研究者
入排标准
入选标准
- •Adult patients, \>/=18 years of age
- •Diagnosis of rheumatoid arthritis
- •Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
- •Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed
排除标准
- •Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
- •Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
- •Patients whose first biologic is rituximab, abatacept or anakinra.
- •Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
结局指标
主要结局
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
时间窗: Baseline and Week 24
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker \[erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)\]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (\</=) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
次要结局
- Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52(Baseline and Week 52)
- Mean Change From Baseline in Erythrocyte Sedimentation Rate(Baseline, Week 24, Week 52)
- Mean Change From Baseline in Swollen Joint Count(Baseline, Week 24, Week 52)
- Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy(Up to Week 52)
- Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events(Up to Week 52)
- Mean Change From Baseline in C-reactive Protein(Baseline, Week 24, Week 52)
- Proportion of Participants Who Terminated Biologic Treatment(Up to Week 52)
- Mean Change From Baseline in Tender Joint Count(Baseline, Week 24, Week 52)
- Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score(Baseline, Week 24, Week 52)
- Mean Change From Baseline in Physician Global Assessment Score(Baseline, Week 24, Week 52)
- Loss of Efficacy or Development of Intolerance to Biologic Therapy(Up to Week 52)
- Reasons for Treatment Discontinuation(Up to Week 52)
- Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period(Up to end of treatment)
- Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score(Baseline, Week 24, Week 52)
- Shift From Baseline in Morning Stiffness(Baseline, Week 24, Week 52)
- Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study(Up to Week 52)
- Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score(Baseline, Week 24, Week 52)
- Mean Change From Baseline in Visual Analogue Scale Pain Score(Baseline, Week 24, Week 52)
- Change From Baseline in Patient Global Assessment of Disease Activity(Baseline, Week 24, Week 52)