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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients >/=18 years of age

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

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

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

Exclusion Criteria:

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