drugset / Trial / NCT01390545

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

NCT01390545

Phase 2 Terminated 300 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2011-08
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator veltuzumab Monoclonal antibody 80 mg Subcutaneous
Comparator veltuzumab Monoclonal antibody 160 mg Subcutaneous
Comparator veltuzumab Monoclonal antibody 320 mg Subcutaneous

Indications