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Clinical Trials in France / NCT04664465
Active, not recruiting Observational

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

NCT04664465 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-03-18
Last updated
2026-06-12

Condition(s) studied

Inflammatory RheumatismPolymyalgia RheumaticaGiant Cell ArteritisIdiopathic Inflammatory MyopathiesANCA Associated VasculitisSystemic Autoimmune Disease

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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 - Service de Médecine interne Nantes France
CHU de Nantes - Service de Rhumatologie 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

More University Hospital, Brest trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04664465 on ClinicalTrials.gov ↗ ← All trials in France