Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
研究概览
简要总结
This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.
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
- •adult patients >/= 18 years of age
- •moderate to severe active rheumatoid arthritis
- •inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
- •DAS >3.6
- •pneumology examination (including chest x-ray and quantiferon)
排除标准
- •< 18 years of age
- •active infection
- •active tuberculosis
- •uncontrolled hyperlipoproteinaemia
- •demyelinating disorders
- •concomitant anti-TNF drugs
- •history of intestinal ulceration and diverticulitis
研究组 & 干预措施
Single Arm
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
时间窗: Weeks 0, 4, 8, 12, 16, and 20
Percentage of Participants Adherent to Original Treatment
时间窗: Week 24
Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.
Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason
时间窗: Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason
时间窗: Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Withdrawing From the Study Prematurely for Any Reason
时间窗: Weeks 0, 4, 8, 12, 16, 20, and 24
次要结局
- Disease Activity Score Based on 28-Joint Count (DAS28)(Weeks 0, 4, 12, and 24)
- Patient Global Assessment of Disease Activity(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate (ESR)(Weeks 0, 4, 12, 20, and 24)
- C-Reactive Protein (CRP)(Weeks 0, 4, 12, 20, and 24)
- Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Patient Global Assessment of Pain(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Physician's Global Assessment of Disease Activity(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Swollen Joint Count (SJC)(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Tender Joint Count (TJC)(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Short Form-36 (SF-36)(Weeks 0, 12, and 24)