PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS

Last updated: February 10, 2025
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatic Fever

Vascular Diseases

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT04664465
29BRC20.0274
  • Ages 18-85
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Life expectancy > 1 year.

  • Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day forthe treatment of an inflammatory rheumatic disease.

  • Initial treatment or relapse.

  • Previsional treatment duration > 3 months.

Exclusion

Exclusion Criteria:

  • Unable to consent.

  • Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mgper day).

Study Design

Total Participants: 300
Study Start date:
March 18, 2021
Estimated Completion Date:
March 18, 2026

Connect with a study center

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHRU de Brest

    Brest, 29609
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • CH Le Mans

    Le Mans, 72000
    France

    Active - Recruiting

  • CH des Pays de Morlaix

    Morlaix, 29672
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHR d'Orléans

    Orléans, 45067
    France

    Site Not Available

  • <CHU de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHIC Quimper

    Quimper, 29000
    France

    Active - Recruiting

  • Clinique St Exupéry

    Toulouse,
    France

    Active - Recruiting

  • CHU de Tours

    Tours, 37044
    France

    Active - Recruiting

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