A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Last updated: October 12, 2011
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT01187563
0000-RA-1008
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years of age

  • Moderately to severely active rheumatoid arthritis

  • Inadequate response to previous treatment with an anti-TNF agent

  • Receiving methotrexate for at least 12 wks before study

Exclusion

Exclusion Criteria:

  • Previous treatment with tocilizumab

  • Previous treatment with other IL-6 receptor inhibitors

  • Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks

  • Conditions noted in the tocilizumab prescribing information

Study Design

Total Participants: 16
Study Start date:
August 01, 2010
Estimated Completion Date:
December 31, 2010

Study Description

This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Connect with a study center

  • Worcester, Massachusetts
    United States

    Site Not Available

  • Duncansville, Pennsylvania
    United States

    Site Not Available

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