NCT00779220

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

A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	placebo	Intravenous repeating dose
DRUG	methotrexate	Oral repeating dose
DRUG	ocrelizumabu 50mg	Intravenous repeating dose (50mg)
DRUG	ocrelizumabu 200mg	Intravenous repeating dose (200mg)
DRUG	ocrelizumab 500mg	Intravenous repeating dose (500mg)

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2015-03-01
• First posted: 2008-10-24
• Last updated: 2015-03-25

Locations

7 sites across 1 country: Japan