Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments methotrexate, ocrelizumab, placebo
Phase phase 3
Sponsor Genentech, Inc.
Collaborator Roche Pharma AG
Start date December 2006
End date September 2011
Trial size 1015 participants
Trial identifier NCT00406419, ACT3985g, WA20494

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
methotrexate
Oral repeating dose
ocrelizumab
Intravenous repeating dose (200mg)
(Experimental)
methotrexate
Oral repeating dose
ocrelizumab
Intravenous repeating dose (500mg)
(Placebo Comparator)
methotrexate
Oral repeating dose
placebo
Intravenous repeating dose

Primary Outcomes

Measure
Percentage of patients with ACR 20 response
time frame: Weeks 24 and 48

Secondary Outcomes

Measure
Proportion of patients with a major clinical response
time frame: Week 48
The proportion of patients achieving Disease Activity Score (DAS28) remission
time frame: Weeks 24 and 48
Change in DAS28 from baseline
time frame: Weeks 24 and 48
EULAR response rates
time frame: Weeks 24 and 48
Proportion of patients achieving an ACR50 response
time frame: Weeks 24 and 48
Proportion of patients achieving an ACR70 response
time frame: Weeks 24 and 48

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Adult patients, ≥18 years of age - Rheumatoid arthritis for ≥ 3 months - Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks Exclusion criteria: - Rheumatic autoimmune disease or inflammatory joint disease, other than RA - Prior receipt of any biologic therapy for RA - Concurrent treatment with any DMARD (other than methotrexate)

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..