An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
研究概览
简要总结
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 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
- •Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)
- •Current treatment at stable dose for >/=8 weeks
- •Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- •Rheumatic autoimmune disease other than RA
- •Functional class IV (American College of Rheumatology Classification)
- •Prior history or current inflammatory joint disease other than RA
- •Oral corticosteroids at a dose of >10 mg/day prednisone equivalent
- •Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
- •Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
- •History of or currently active primary or secondary immunodeficiency
研究组 & 干预措施
Single Arm
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
时间窗: Baseline, Week 24
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population
时间窗: Baseline, Week 48
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population
时间窗: Baseline, Week 72
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population
时间窗: Baseline, Week 96
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population
时间窗: Baseline, Week 24
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population
时间窗: Baseline, Week 48
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population
时间窗: Baseline, Week 72
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. 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 participant's 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 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population
时间窗: Baseline, Week 96
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. 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 participant's 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 (worst score) to 52 (best score).
次要结局
- Erythrocyte Sedimentation Rate(Baseline; Weeks 8, 16, 24, 36 48, 72 and 96)
- Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study(Baseline, End of the study (up to Week 100))
- Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96(Weeks 24, 48, 72 and 96)
- Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96(Weeks 24, 48, 72 and 96)
- Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96(Weeks 24, 48, 72 and 96)
- Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96(Weeks 24, 48, 72 and 96)
- Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96(Weeks 24, 48, 72 and 96)
- Change From Baseline in TJC At Weeks 24, 48, 72, and 96(Baseline; Weeks 24, 48, 72 and 96)
- Change From Baseline in SJC At Weeks 24, 48, 72, and 96(Baseline; Weeks 24, 48, 72 and 96)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96(Weeks 24, 48, 72 and 96)
- Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96(Baseline; Weeks 20, 44, 72 and 96)
- C-reactive Protein Level(Baseline; Weeks 8, 16, 24, 36 48, 72 and 96)
- Participant Assessment of Pain (VAS)(Baseline; Weeks 8, 16, 24, 36 48, 72 and 96)
- Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96(Baseline; Weeks 24, 48, 72 and 96)