An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis
Overview
- Phase
- Phase 3
- Intervention
- tocilizumab [RoActemra/Actemra]
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 30
- Primary Endpoint
- Safety (incidence of adverse events)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients, \>/=18 years of age
- •Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
- •Patients successfully completed studies WA17823 and WA18696 in South Africa
- •Body weight \<150 kg
Exclusion Criteria
- •Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
- •Previous treatment with any cell depleting therapies
- •Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
Arms & Interventions
1
Intervention: tocilizumab [RoActemra/Actemra]
Outcomes
Primary Outcomes
Safety (incidence of adverse events)
Time Frame: 104 weeks
Safety (laboratory assessments e.g. hematology)
Time Frame: 104 weeks
Secondary Outcomes
- Efficacy: Change in Disease Activity Score (DAS28)(104 weeks)