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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 105
- Locations
- 27
- Primary Endpoint
- Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
1
Intervention: tocilizumab [RoActemra/Actemra] (Drug)
1
Intervention: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs) (Drug)
Outcomes
Primary Outcomes
Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)