Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment (CONIFER)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: NSAIDs; Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03112213

ML30088

Details and patient eligibility

About

This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
• Current users of NSAIDs due to RA as assessed by the physician

Exclusion criteria

• Contraindications to treatment with tocilizumab as per SPC
• Prior therapy with tocilizumab

Trial design

135 participants in 1 patient group

Participants With RA

Description:

Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.

Treatment:

Drug: NSAIDs

Drug: Tocilizumab