A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis
Summary
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.
Timeline
- Start
- 2011-03
- Primary completion
- 2014-02
- Completion
- 2014-02
Outcome
Missed primary endpoint
registry p = 0.1648; Exact one-sided binomial test NCT01332994 ↗
registry NUMBER TCZ/TCZ or TCZ/RTX: 42.8 (38.5 to 47.2) percentage of participants NCT01332994 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1 g | Intravenous |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |