RecruitingNCT04664465

PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS


Sponsor

University Hospital, Brest

Enrollment

300 participants

Start Date

Mar 18, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria2

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

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Locations(11)

CHU d'Angers

Angers, France

CHRU de Brest

Brest, France

CHD Vendée

La Roche-sur-Yon, France

CH Le Mans

Le Mans, France

CH des Pays de Morlaix

Morlaix, France

CHU de Nantes

Nantes, France

CHR d'Orléans

Orléans, France

<CHU de Poitiers

Poitiers, France

CHIC Quimper

Quimper, France

Clinique St Exupéry

Toulouse, France

CHU de Tours

Tours, France

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NCT04664465


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