PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS

Recruiting

• Conditions: Polymyalgia Rheumatica; Inflammatory Rheumatism; ANCA Associated Vasculitis; Systemic Autoimmune Disease; Idiopathic Inflammatory Myopathies; Giant Cell Arteritis

• Registration Number: NCT04664465
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Study Start: 2021-03-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-03-18
• Study Completion: 2026-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically relevant complication of glucocorticoid therapy	1 year	The occurrence of one or more clinically relevant complication of glucocorticoid therapy during the first year of treatment, according to the Glucocorticoid Toxicity Index (items and specific list).

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed through SF-36	1 year

Trial Locations

Locations (11)

<CHU de Poitiers; 🇫🇷 Poitiers, France

Clinique St Exupéry; 🇫🇷 Toulouse, France

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

CHIC Quimper; 🇫🇷 Quimper, France

CHU de Nantes; 🇫🇷 Nantes, France

CHR d'Orléans; 🇫🇷 Orléans, France

CHU de Tours; 🇫🇷 Tours, France