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

No results posted yet for this study

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

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112213 on ClinicalTrials.gov