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.

  • Rheumatoid Arthritis
Trial Status:

Completed

This trial runs in
Cities
  • Skåne län
  • Skövde
  • Uppsala län
  • Värmlands län
  • Örebro län
Trial Identifier:

NCT02679001 ML29933

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      NCT02679001 , ML29933 Trial Identifier
      TNF inhibitor/TCZ Treatments
      Rheumatoid Arthritis Condition
      Official Title

      A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      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).

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