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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01617005

ML25699

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Tocilizumab in Moderate to Severe Active RA

Description:

Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Treatment:

Drug: Tocilizumab