Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

  • Rheumatoid Arthritis
Trial Status:


This trial runs in
  • Budapest
  • Debrecen
  • Eger
  • Esztergom
  • Gyula
  • Győr
  • Heviz
  • Kecskemét
  • Kistarcsa
  • Miskolc
  • Nyíregyháza
  • Pécs
  • Szeged
  • Szombathely
  • Székesfehérvár
  • Veszprém
Trial Identifier:

NCT02402686 ML29719

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

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

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      Trial Summary

      The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.

      Hoffmann-La Roche Sponsor
      NCT02402686 , ML29719 Trial Identifier
      Tocilizumab Treatments
      Rheumatoid Arthritis Condition
      Official Title

      Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
      • Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
      • Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate
      Exclusion Criteria
      • Treatment with tocilizumab more than 8 weeks prior to enrollment
      • Failure to meet local tocilizumab label indication criteria
      • Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
      • Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
      • History of any other autoimmune or joint inflammatory disease

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