Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Rheumatoid Arthritis RA SCRIPT anti-CD20 CD20 Arthritis Arthritis, Rheumatoid Methotrexate Leflunomide ocrelizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Rheumatic autoimmune disease or inflammatory joint disease, other than RA
  • Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

Locations

  • Ucsd, Dept of Medicine; Rheumatology
    San Diego California 92093 United States
  • Allergy & Rheumatology Centre
    La Jolla California 92037 United States
  • San Diego Arthritis Med Clnc
    San Diego California 92108 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT00476996
Phase
Phase 3
Study Type
Interventional
Last Updated
August 30, 2018