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临床试验/NCT00951275
NCT00951275已完成3 期

A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.

Hoffmann-La Roche27 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2009年10月31日最近更新:
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
105
试验地点
27
主要终点
Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin

研究概览

简要总结

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

入选标准

  • adult patients, >=18 years of age;
  • rheumatoid arthritis >=6 months duration;
  • DAS28>=3.2;
  • inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

排除标准

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • history of or current inflammatory joint disease other than rheumatoid arthritis;
  • unsuccessful treatment with an anti-TNF agent;
  • previous/concurrent treatment with any cell-depleting therapies.

研究组 & 干预措施

1

Experimental

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

1

Experimental

干预措施: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs) (Drug)

结局指标

主要结局

Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin

时间窗: Week 4

Hemoglobin levels were measured as grams/deciliter (g/dL).

Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores

时间窗: Week 4

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.

次要结局

  • Mean Hemoglobin Levels During the Study(Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Improvement of Anemia Assessed as Change From Baseline in Hemoglobin(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • FACIT-F Scores(Baseline, Weeks 2, 4, 8,12, 16, 20 and 24)
  • Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percent Change From Baseline to Week 24 in TJC(Week 24)
  • Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement(Week 24)
  • Percent Change From Baseline to Week 24 in SJC(Week 24)
  • Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain(Week 24)
  • Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity(Week 24)
  • Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity(Week 24)
  • Percent Change From Baseline to Week 24 in HAQ-DI(Week 24)
  • Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)(Week 24)
  • Percent Change From Baseline to Week 24 in ESR(Week 24)
  • Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category(Week 24)
  • Percentage of Participants With a Response at Week 24 by DAS28 Category(Week 24)
  • Percent Change From Baseline to Week 24 in DAS28 Score(Week 24)
  • Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin(Week 24)
  • Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)(Baseline)
  • Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ(Weeks 12 and 24)
  • Number of Hours as Assessed by SF-HLQ(Baseline)
  • Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ(Baseline)
  • SF-HLQ Hindrance Score(Baseline)
  • Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score(Baseline)
  • Efficiency as Assessed by SF-HLQ(Baseline)
  • Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (27)

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