Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

NCT ID: NCT01683604

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis (RA) Participants (All Groups)

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

Observational study

Intervention Type: OTHER

Interventions

Observational study

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Campsie, New South Wales, Australia

Coffs Harbour, New South Wales, Australia

New Lambton, New South Wales, Australia

Woodville, South Australia, Australia

Heidelberg, Victoria, Australia

Morwell, Victoria, Australia

Shenton Park, Western Australia, Australia

Countries

Australia

Other Identifiers

ML28144

Identifier Type: -

Identifier Source: org_study_id