A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Change From Week 12 (Randomization) to Week 24 in DAS28
研究概览
简要总结
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.
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
- •Rheumatoid arthritis of >/= 1 year duration
- •Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
- •On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
- •Body weight </= 150 kg
- •Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline
排除标准
- •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 rheumatoid arthritis
- •Functional class IV American College of Rheumatology (ACR) Classification
- •Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- •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 tocilizumab
- •Pregnant or lactating women
- •Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- •Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- •History of or currently active primary or secondary immunodeficiency
- •Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
- •Active tuberculosis requiring treatment within the previous 3 years
- •Positive for HIV infection
研究组 & 干预措施
A Methotrexate
干预措施: methotrexate (Drug)
A Methotrexate
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
B Methotrexate Placebo
干预措施: methotrexate (Drug)
B Methotrexate Placebo
干预措施: placebo (Drug)
B Methotrexate Placebo
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Change From Week 12 (Randomization) to Week 24 in DAS28
时间窗: Weeks 12 and 24
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement.
次要结局
- Percentage of Participants With DAS28 Remission at Week 24(Week 24)
- vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24(Week 24)
- Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24(Week 24)
- Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24(Week 24)
- Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Weeks 12 and 24)
- Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score(Weeks 12 and 24)
- Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores(Weeks 12 and 24)
- Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score(Week 24)