Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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* Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (incidence of adverse events) | 104 weeks |
| Safety (laboratory assessments e.g. hematology) | 104 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Change in Disease Activity Score (DAS28) | 104 weeks |
Countries
South Africa
Outcome results
None listed