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