NCT01468077已完成2 期
Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Percentage of Participants With Any Infusion Reaction
研究概览
简要总结
This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 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
- 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, at least 18 years of age, inclusive
- •Diagnosis of rheumatoid arthritis of at least 6 months duration
- •Moderate to severe active rheumatoid arthritis (DAS28 >/=3.2)
- •Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
- •Rheumatic autoimmune disease other than rheumatoid arthritis
- •Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- •Functional class IV (ACR criteria)
- •History of severe allergic reaction to human, humanized or murine monoclonal antibodies
- •Known active current or history of recurrent infection (including tuberculosis)
- •Primary or secondary immunodeficiency (history of or currently active)
- •Body weight >150 kg
- •Previous treatment with any cell-depleting therapies
- •Previous treatment with tocilizumab
研究组 & 干预措施
Tocilizumab, Normal Administration
Experimental
Tocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions (up to 24 weeks)
干预措施: Tocilizumab (Drug)
Tocilizumab, Fast Administration
Experimental
Tocilizumab 8 mg/kg infusion of 31 minutes duration every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour. If an infusion reaction occurred during any treatment, 1 hour infusions were used for all subsequent infusions
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants With Any Infusion Reaction
时间窗: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.
次要结局
- Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)(Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20 and 24)
- Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits(Weeks 4, 8. 12, 20, and 24)
- Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits(Weeks, 4, 8, 12, 16, 20, and 24)
- High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits(Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Discontinuing Tocilizumab for Other Reasons(Baseline and Weeks, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits(Screening and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
- DAS28 Score by Visit Among Participants Who Completed All Visits(Baseline, Weeks, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20 and 24)
- Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits(Baseline, Weeks 4, 8, 12, 20, and 24)
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