Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT01683604

ML28144

Details and patient eligibility

About

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe RA.
• Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
• Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.

Exclusion criteria

• Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
• Previous tocilizumab treatment in a clinical trial or for compassionate use.
• Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
• History of autoimmune disease or any joint inflammatory disease other than RA.

Trial design

37 participants in 1 patient group

Rheumatoid Arthritis (RA) Participants (All Groups)

Description:

Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.

Treatment:

Other: Observational study