NCT01235507已完成3 期
Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
研究概览
简要总结
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Active moderate to severe rheumatoid arthritis (RA)
- •On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
- •Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
- •Body weight </= 150 kg
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
- •Rheumatic autoimmune disease other than RA
- •Functional class IV according to American College of Rheumatology (ACR) classification
- •Prior history of or current inflammatory joint disease other then RA
- •Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- •Treatment with any biologic drug that is used in the treatment or RA
- •Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •Known active current or history of recurrent infection
- •History of or currently active primary or secondary immunodeficiency
- •Positive for HIV
研究组 & 干预措施
Single Arm
Experimental
干预措施: methotrexate (Drug)
Single Arm
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
时间窗: Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24
AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.
次要结局
- Swollen and Tender Joint Counts(Baseline, Weeks 8, 16 and 24)
- Physician's Global Assessment of Disease Activity(Baseline, Weeks 8, 16 and 24)
- Participant's Global Assessment of Disease Activity(Baseline, Weeks 8, 16 and 24)
- Participant's Global Assessment of Pain(Baseline, Weeks 8, 16 and 24)
- Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit(Baseline, Weeks 8, 16 and 24)
- Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28(Weeks 8, 16 and 24)
- CRP Levels(Baseline, Weeks 8, 16 and 24)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 8, 16 and 24)
研究者
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