A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 主要终点
- Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28
研究概览
简要总结
This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
- •Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- •Body weight < 150 kg
- •Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day
排除标准
- •Pregnant or nursing women
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- •Rheumatic autoimmune disease other than RA
- •Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- •Prior history of or current inflammatory joint disease other than RA
- •Treatment with a biologic agent at any time prior to baseline
- •Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- •Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •Previous treatment with RoActemra/Actemra
- •History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •Known active current or history of recurrent infection
- •History of or currently active primary or secondary immunodeficiency
- •Active tuberculosis requiring treatment within the previous 3 years
- •Positive for HIV infection
研究组 & 干预措施
A
干预措施: methotrexate (Drug)
A
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
B
干预措施: methotrexate (Drug)
B
干预措施: placebo (Drug)
B
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28
时间窗: Baseline, Week 16, and Week 28
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
次要结局
- Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28(Week 28)
- Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28(Week 28)
- Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28(28 weeks)
- Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28(Week 16 and Week 28)
- Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health(Week 16 and Week 28)
- Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health(Week 16 and Week 28)
- Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant(Week 16 and Week 28)
- Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator(Week 16 and Week 28)