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A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

NCT02679001

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: TNF inhibitor/TCZ

Countries: Sweden

This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* At least 18 years of age.
* With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
* Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
* The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
* Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.

Exclusion Criteria:

* Have had more than one TNF-inhibitor prior to the enrolment visit.
* Have had biological treatment other than TNF-inhibitors.
* Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).

Locations (11)

Arvika, Sweden
Eskilstuna, Sweden
Huddinge, Sweden
Karlskrona, Sweden
Malmö, Sweden
Malmö, Sweden
Örebro, Sweden
Skövde, Sweden
Stockholm, Sweden
Trelleborg, Sweden
Uppsala, Sweden