A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 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:

• adult patients, >=18 years of age;

• rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;

• DAS28 of >3.2;

• At screening either ESR >=28 mm/h or CRP >=1 mg/dL;

• Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.

Exclusion Criteria:

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

• functional class IV as identified by the ACR classification of functional status in RA;

• rheumatoid autoimmune disease other than RA;

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