An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

Last updated: February 10, 2015
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Bone Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT01254331
ML22642
  • Ages > 18
  • All Genders

Study Summary

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients >/=18 years of age

  • Moderate to severe rheumatoid arthritis defined as DAS 28>3.2

  • Body weight </=150 kg

  • Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at anytime prior to study start

  • Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion

Exclusion Criteria:

  • Major surgery within 8 weeks prior to screening or planned major surgery within 6months following enrollment

  • Rheumatic autoimmune disease other than rheumatoid arthritis (RA)

  • Functional class IV as defined by the ACR classification

  • History or current inflammatory joint disease other than RA

  • Previous treatment with any cell depleting therapy

  • Previous treatment with methotrexate

  • Previous treatment with tocilizumab

  • Previous treatment with any biologic drug that is used in the treatment of RA

Study Design

Total Participants: 51
Study Start date:
February 01, 2011
Estimated Completion Date:
February 28, 2013

Connect with a study center

  • Sfax, 3000
    Tunisia

    Site Not Available

  • Sousse, 4000
    Tunisia

    Site Not Available

  • Tunis, 2046
    Tunisia

    Site Not Available

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