VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Status:
Terminated
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm
parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of
veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc)
injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative
veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on
continued stable co-medication with methotrexate (MTX).