An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.
Overview
- Phase
- Phase 3
- Intervention
- tocilizumab [RoActemra/Actemra]
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 14
- Locations
- 3
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •moderate to severe rheumatoid arthritis;
- •inadequate response to current non-biologic DMARDs
Exclusion Criteria
- •rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- •previous treatment with other biologics.
Arms & Interventions
1
Intervention: tocilizumab [RoActemra/Actemra]
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. AEs included both serious as well as non-serious AEs.
Secondary Outcomes
- Disease Activity Score (DAS28)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response(Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein (CRP) Level(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Neutrophil Count(Baseline, Weeks 4, 8, and 12)
- Percentage of Participants Who Discontinued the Study(Up to Week 24)
- Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal(Up to Week 24)
- Percentage of Participants With Lipid Level Elevations(Week 24)