Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments leflunomide, methotrexate, ocrelizumab, placebo
Phase phase 3
Sponsor Genentech, Inc.
Collaborator Roche Pharma AG
Start date May 2007
End date August 2011
Trial size 840 participants
Trial identifier NCT00476996, ACT3986g, WA20495

Summary

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. 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 stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. 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)
leflunomide
Oral repeating dose
methotrexate
Oral or parenteral repeating dose
ocrelizumab
Intravenous repeating dose (200mg)
(Experimental)
leflunomide
Oral repeating dose
methotrexate
Oral or parenteral repeating dose
ocrelizumab
Intravenous repeating dose (500mg)
(Placebo Comparator)
leflunomide
Oral repeating dose
methotrexate
Oral or parenteral repeating dose
placebo
Intravenous repeating dose

Primary Outcomes

Measure
Percentage of patients with ACR20 responses
time frame: Weeks 24 and 48

Secondary Outcomes

Measure
Proportion of patients with a major clinical response
time frame: Week 48
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
Proportion of patients with a reduction in the HAQ-DI score
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 response to previous or current treatment with at least one anti-TNF-alpha agent - Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks Exclusion Criteria: - Rheumatic autoimmune disease or inflammatory joint disease, other than RA - Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

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 Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..