drugset / Trial / NCT00603525

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

NCT00603525

Phase 3 Terminated 169 enrolled GlaxoSmithKline
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

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 35 ml Intravenous

Indications