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

Sponsor
Hoffmann-La Roche
Study ID
NCT03112213
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.
  • NSAIDs — DRUG
    Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Study Details

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).

Key Dates

Start date
Jan 12, 2017
Status verified
Dec 2018
Primary completion
Jul 17, 2018
Completion
Jul 17, 2018

Study Design

Enrollment
135 participants (estimated)

Arms

  • Arm: Participants With RA
    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.

Primary Outcome Measure

Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration [ Time Frame: Day -14 to Day 0 (Baseline) ]

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