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

Hoffmann-La Roche135 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Rheumazentrum Kupka

Altenburg, Germany

Praxis für Rheumatologie.

Amberg, Germany

Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

Bad Nauheim, Germany

Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

Berlin, Germany

Praxis für Innere Medizin - Rheumatologie

Berlin, Germany

Rheuma Praxis Berlin Sven Remstedt

Berlin, Germany

Praxis Dr. Silke Zinke

Berlin, Germany

Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken

Burghausen, Germany

Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

Dresden, Germany

Praxis Dr. med. Semmler; Facharzt für Innere Medizin

Güstrow, Germany

...and 17 more locations

Outcomes

Primary Outcomes

Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration

Time frame: Day -14 to Day 0 (Baseline)

Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration

Time frame: 14 days after 6-8 weeks of tocilizumab administration

Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration

Time frame: 14 days after 12-16 weeks of tocilizumab administration

Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration

NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (\>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (\</=) 100%.

Time frame: Day -14 to Day 0 (Baseline)

Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration

NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.

Time frame: 14 days after 6-8 weeks of tocilizumab administration

Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration

NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.

Time frame: 14 days after 12-16 weeks of tocilizumab administration