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

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Tumor Necrosis Factor Inhibitors

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).