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PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

Recruiting
18 - 85 years of age
Both
Phase N/A

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Overview

To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.

Eligibility

Inclusion Criteria:

  • Life expectancy > 1 year.
  • Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
  • Initial treatment or relapse.
  • Previsional treatment duration > 3 months.

Exclusion Criteria:

  • Unable to consent.
  • Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).

Study details

Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis

NCT04664465

University Hospital, Brest

27 January 2024

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