drugset / Trial / NCT02720120

A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

NCT02720120

Phase 1/2 Terminated 175 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.

Timeline

Start
2005-10
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 400 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 1000 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 1500 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 2000 mg Intravenous

Indications