An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• male and non-pregnant or nursing female patients >=18 years of age;

• body weight <=150kg;

• moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;

• on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;

• inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;

• if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.

Exclusion Criteria:

• major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;

• rheumatic autoimmune disease other than RA;

• prior history of, or current inflammatory joint disease other than RA;

• functional class IV as defined by the ACR Classification of Functional Status in RA.