NCT00406419

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,015 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate tablet was administered orally at a dose 7.5-25 mg
DRUG	ocrelizumab	Ocrelizumab was administered via IV infusion at a dose specified in arm description
DRUG	Placebo	Matching placebo to ocrelizumab was administered via IV infusion

Timeline

• Start date: 2006-12-27
• Primary completion: 2009-10-06
• Completion: 2015-04-22
• First posted: 2006-12-04
• Last updated: 2020-11-27
• Results posted: 2020-11-27

Locations

1 site across 1 country: United States