drugset / Trial / NCT01245452
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate
RandomizedParallel-groupDouble-blindTreatment
Summary
To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone. The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety profile of Tocilizumab.
Timeline
- Start
- 2010-05
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8 | Unknown | 20 mg | — |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | — |