drugset / Trial / NCT01101555
Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study
RandomizedSingle-groupSingle-blindTreatment
Summary
This study is a randomised, single-blind, placebo-controlled, repeat dose study of otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will receive a single dose of adalimumab (HUMIRA, Abbott) as rescue medication to assess additional concomitant safety and tolerability issues.
Timeline
- Start
- 2010-05-12
- Primary completion
- 2011-09-16
- Completion
- 2012-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Otelixizumab | Monoclonal antibody | 1.5 mg | Subcutaneous |
| Subject | Otelixizumab | Monoclonal antibody | 3.5 mg | Subcutaneous |
| Subject | Otelixizumab | Monoclonal antibody | 6 mg | Subcutaneous |
| Subject | Otelixizumab | Monoclonal antibody | 8 mg | Subcutaneous |
| Subject | Otelixizumab | Monoclonal antibody | 10 mg | Subcutaneous |
| Subject | Otelixizumab | Monoclonal antibody | 15 mg | Subcutaneous |