NCT01669902已完成不适用
HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Percentage of Participants on Tocilizumab Treatment at Month 6
研究概览
简要总结
This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment 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 patients, >/= 18 years of age
- •Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- •Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
- •Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed
排除标准
- •Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
- •Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- •Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
- •Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
结局指标
主要结局
Percentage of Participants on Tocilizumab Treatment at Month 6
时间窗: Month 6
次要结局
- Percentage of Participants With Dose Modifications of Tocilizumab(Baseline to Month 6)
- Swollen Joint Count (SJC)(Baseline, Month 3, Month 6)
- Tender Joint Count (TJC)(Baseline, Month 3, Month 6)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])(Baseline, Month 3, Month 6)
- Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)(Month 3 and Month 6)
- Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Month 3, Month 6)
- Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)(Month 3 and Month 6)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)(Month 3 and Month 6)
- Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)(Month 3 and Month 6)
- Simplified Disease Activity Index (SDAI)(Baseline, Month 3, Month 6)
- Percentage of Participants Achieving Clinical Remission Based on SDAI(Month 3 and Month 6)
- Clinical Disease Activity Index (CDAI)(Baseline, Month 3, Month 6)
- Percentage of Participants Achieving Clinical Remission Based on CDAI(Month 3 and Month 6)
- Number of Participants With an American College of Rheumatology (ACR) Response(Baseline to Month 6)
- Patient Global Assessment (PtGA) of Disease Activity Score(Baseline, Month 3, Month 6)
- Physician Global Assessment (PGA) of Disease Activity(Baseline, Month 3, Month 6)
- Percentage of Participants in a PGA of Disease Activity Score Category(Baseline, Month 3, Month 6)
- Patient Global Assessment of Pain(Baseline, Month 3, Month 6)
- Percentage of Participants With Morning Stiffness(Baseline, Month 3, Month 6)
- Percentage of Participants With Duration of Morning Stiffness(Baseline, Month 3, Month 6)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6(Baseline, Month 3 and Month 6)
- Percentage of Participants With Concomitant Corticosteroids Treatment(Baseline to Month 6)
- Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study(Baseline to Month 6)
研究者
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