Overview

A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Antirheumatic Agents
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- Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to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