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.

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: TNF inhibitor/TCZ

Study type: Observational

Funder types: Industry

Identifiers

NCT02679001

ML29933

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

200 participants in 1 patient group

RA participants treated with a TNF inhibitor or TCZ

Description:

Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.

Treatment:

Drug: TNF inhibitor/TCZ