drugset / Trial / NCT00754572
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.
Timeline
- Start
- 2009-02
- Primary completion
- 2012-10
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 10 mg | Oral |
| Subject | Methotrexate | Small molecule | 25 mg | Oral |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |