A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

• Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)

• Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists

• Initiating treatment with tocilizumab according to SPC

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA

• Prior history or current inflammatory joint disease other than RA

• Previous treatment with any biological drug used in the treatment of RA

• Previous treatment with tocilizumab

• Any contraindication to treatment with tocilizumab

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

• Pregnant women or nursing (breastfeeding) mothers