drugset / Trial / NCT00779220

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

NCT00779220

Phase 2 Terminated 152 enrolled Chugai Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate(MTX)in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

Timeline

Start
2008-10
Primary completion
2010-02
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 50 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 200 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 500 mg Intravenous
Background Methotrexate Small molecule Oral

Indications