drugset / Trial / NCT00965653
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
RandomizedParallel-groupOpen-labelTreatment
Summary
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.
Timeline
- Start
- 2009-08
- Primary completion
- —
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tocilizumab | Monoclonal antibody | 162 mg | Subcutaneous |
| Background | Methotrexate | Small molecule | 7.5 mg | — |
| Background | Methotrexate | Small molecule | 25 mg | — |
| Background | folic acid | Other / unclassified | 5 mg | — |