drugset / Trial / NCT00603525
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.
Timeline
- Start
- 2008-01
- Primary completion
- 2011-03
- Completion
- 2013-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofatumumab | Monoclonal antibody | 35 ml | Intravenous |