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

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 of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

Timeline

Start

2008-01-01

Primary completion

2009-06-08

Completion

2013-07-15

Outcome

Met primary endpoint

Stopped: “Ofatumumab IV trials in RA were prematurely terminated because GSK refocused clinical development of autoimmune indications on the subcutaneous delivery.”

registry analysis (superiority or other test); Placebo vs Ofatumumab 700 mg; p <0.001; Odds Ratio (OR) 2.86 (95% CI 1.67 to 4.91); Cochran-Mantel-Haenszel NCT00611455 ↗

release “ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint” gsk.com ↗

Publications

• Background Taylor PC, Quattrocchi E, Mallett S, Kurrasch R, Petersen J, Chang DJ. Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis. 2011 Dec;70(12):2119-25. doi: 10.1136/ard.2011.151522. Epub 2011 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ofatumumab	Monoclonal antibody	700 mg	Intravenous

Indications