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Therapeutic Areas: Rheumatology | Musculoskeletal | Immunology | Family Medicine
Disease Category: Rheumatoid Arthritis
Location: United States, MD

Clinical Trial Details

Overview

Research Study Summary

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate

Purpose

A randomized, double-blind study of the effect of ocrelizumab in combination with methotrexate, compared to methotrexate alone, on the treatment response in methotrexate-naive patients with active rheumatoid arthritis.

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200 mg i.v. or ocrelizumab 500 mg i.v. on days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20 mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. In the US this study is sponsored/managed by Genentech, under protocol no. ACT3984g.

Patient Inclusion Criteria:

  • Adult patients, = 18 years of age;
  • Rheumatoid arthritis for 3 months-5 years;
  • Naive to methotrexate;
  • If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline.

Patient 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.

Primary Outcomes: Change from baseline in modified total Sharp score at week 52

Key Secondary Outcomes: Efficacy:HAQ-DI, ACR20/50/70/90,DAS28,EULAR response rate, erosion score, JSN score,radiographic progression, SF-36, FACIT-F. Safety: AEs.lab parameters

Intervention Type: Drug
Intervention Name: ocrelizumab
Sponsor: Hoffmann-La Roche; Genentech Inc

For more information,

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Lynn Spencer, CRC, RN
The Osteoporosis & Clinical Trials Center
921 Seton Drive
Cumberland, MD 21502
Phone: 1-301-724-4337, x3

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Research Center Information: The Osteoporosis & Clinical Trials Center

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 118851

Date Last Changed: July 25, 2013


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