Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment
NCT03112213 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135
Last updated 2018-12-13
Summary
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).
Conditions
Interventions
- DRUG
-
Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.
- DRUG
-
NSAIDs
Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-12
- Primary Completion
- 2018-07-17
- Completion
- 2018-07-17
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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