NCT01878318撤回4 期
Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale
研究概览
简要总结
This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.
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
- •Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of >/= 6 months duration
- •Active moderate to severe rheumatoid arthritis (DAS >/= 3.2)
- •Swollen joint count (SJC) >/= 6, tender joint count >/= 8
- •Synovitis in the dominant hand
- •Inadequate response to stable dose of a non-biological DMARD for at least 3 months
- •Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
- •Patient on outpatient treatment
排除标准
- •Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
- •Rheumatic autoimmune disease other than rheumatoid arthritis
- •American College of Rheumatology (ACR) functional class IV
- •History of or current inflammatory joint disease other than rheumatoid arthritis
- •Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
- •Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
- •Inadequate hematologic, renal or liver function
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Pregnant or lactating women
- •History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
- •Current infections or history of recurrent infections
- •History of or currently active primary or acquired immunodeficiency
- •Active tuberculosis requiring treatment in the previous 3 years
- •Body weight > 150 kg
研究组 & 干预措施
RoActemra/Actemra
Experimental
干预措施: methotrexate (Drug)
RoActemra/Actemra
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale
时间窗: from baseline to Week 24
次要结局
- Radiological changes in the hand according to the modified Sharp scale(from baseline to Week 24)
- Change in disability: Stanford Health Assessment Questionnaire(from baseline to Week 24)
- Change in Ritchie articular index(from baseline to Week 24)
- Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24(Weeks 12 and 24)
- Change in pain: Visual analogue scale (VAS)(from baseline to Week 24)
- Change in FACIT-fatigue questionnaire(from baseline to Week 24)
- Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)(from baseline to Week 28)
- Change in immunologic parameters: Rheumatic factor/anti-CCP(from baseline to Week 24)
- Safety: Incidence of adverse events(approximately 2 years)
- Change in C-reactive protein(from baseline to Week 24)
研究者
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