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临床试验/NCT01245439
NCT01245439已完成3 期

Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD

Hoffmann-La Roche0 个研究点目标入组 65 人开始时间: 2011年9月最近更新:
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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
65
主要终点
Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 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
  • •Moderate to severe active rheumatoid arthritis (DAS28>/=3.2) of >/=6 months duration
  • •Body weight </=150 kg
  • •Patients are on one or more non-biologic DMARDs at a stable dose for a period >/=8 weeks prior to study treatment
  • •Patients with inadequate clinical response to a stable dose of non-biologic DMARD

排除标准

  • •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  • •Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
  • •History of or current inflammatory joint disease other than rheumatoid arthritis

研究组 & 干预措施

1

Experimental

干预措施: tocilizumab [RoActemra/Actemra] (Drug)

结局指标

主要结局

Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events

时间窗: 24 weeks

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.

次要结局

  • Percentage of Participants With All-Cause Discontinuation(24 weeks)
  • Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants With Serious Infections(Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6))
  • Percentage of Participants Who Achieved LDA By Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Disease Activity Score as Measured By DAS28 at Each Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants With Elevations in Lipids According to ATP III Guidelines(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Mean Number of Tender and Swollen Joints(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Health Assessment Questionnaire Score (General Score)(Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants Achieving Their First Remission Status By Visit(Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response(Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • C-Reactive Protein Levels(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Erythrocyte Sedimentation Rate(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Number of Participants With Serious Infections(Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6))
  • Change From Baseline to Highest Values for ALT and AST(Baseline to Week 24)
  • Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)(Baseline to Week 24)
  • Number of Participants Who Achieved LDA By Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol(Baseline to Week 24)
  • Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants Who Achieved Remission (DAS28) At Every Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Number of Participants Who Achieved Remission (DAS28) By Visit(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response(Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Participant's (PT) and Investigator's (IN) Assessment of Disease Activity(Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))
  • Participant's Assessment of Pain(Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8))

研究者

申办方类型
Industry
责任方
Sponsor

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