An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents

Criteria

Inclusion Criteria:

• Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.

Exclusion Criteria:

• Treatment with any investigational agent since the last administration of study drug in the core studies.

• Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.

• Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.

• Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.

• Previous treatment with any cell-depleting therapies, including investigational agents.

• Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.