NCT00476996

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)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 836 (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 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Leflunomide	Oral repeating dose
DRUG	Methotrexate	Oral or parenteral repeating dose
DRUG	Ocrelizumab	Intravenous repeating dose (200mg)
DRUG	Ocrelizumab	Intravenous repeating dose (500mg)
DRUG	Placebo	Intravenous repeating dose

Timeline

• Start date: 2007-05-15
• Primary completion: 2010-01-21
• Completion: 2018-05-14
• First posted: 2007-05-22
• Last updated: 2019-08-12
• Results posted: 2019-08-12

Locations

266 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan