Safety of Repeated Open-Label Treatment Courses of Intravenous Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, in Rheumatoid Arthritis: Results from Three Clinical Trials.

ABSTRACT:

Objectives

To investigate the safety of ofatumumab retreatment in rheumatoid arthritis.

Methods

Patients with active rheumatoid arthritis participating in two phase III trials (OFA110635 and OFA110634) and a phase II extension trial (OFA111752) received individualised open-label ofatumumab retreatment (700 mg X 2 intravenous infusions two weeks apart) ≥24 weeks following the first course and ≥16 weeks following further courses. Retreatment required evidence of clinical response followed by disease relapse. These studies were prematurely terminated by the sponsor to refocus development on subcutaneous delivery. Due to differences in study designs and populations, data are summarised separately for each study.

Results

483 patients (243, 148 and 92 in OFA110635, OFA11063

SUBMITTER: Quattrocchi E 

PROVIDER: S-EPMC4919033 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature