A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
- Registration Number
- NCT01214733
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Read More
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- Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 tocilizumab [RoActemra/Actemra] -
- Primary Outcome Measures
Name Time Method Safety (incidence of adverse events) 104 weeks Safety (laboratory assessments e.g. hematology) 104 weeks
- Secondary Outcome Measures
Name Time Method Efficacy: Change in Disease Activity Score (DAS28) 104 weeks