A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

• Status: Terminated
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: All

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 treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Roche Pharma AG
• Treatments: Leflunomide; Methotrexate; Ocrelizumab

Criteria

Inclusion Criteria:

• Adult patients, ≥ 18 years of age

• Rheumatoid arthritis for at least 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

• Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline.

• CRP ≥ 0.6 mg/dL using a high-sensitivity assay.

• Positive rheumatoid factor or positive anti-CCP antibody or both.

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