Actively Recruiting
PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS in Inflammatory Rheumatic Diseases
Led by University Hospital, Brest · Updated on 2025-02-11
300
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with inflammatory rheumatic diseases who need long-term glucocorticoid therapy to find factors that predict the risk of serious complications from this treatment. The goal is to create a tool that can estimate the chance of developing these complications within one year, which could help doctors choose the best initial treatments for patients in daily care and future studies. This observational study involves patients starting or restarting glucocorticoid treatment at doses of 15 mg/day or higher, planned for more than three months. There are no experimental drugs or procedures; instead, participants are monitored to collect routine clinical data, biological tests, and bone density scans (DXA) at the beginning of treatment. Participants will be followed for one year to observe any clinically important complications related to glucocorticoid use. Researchers will assess quality of life using the SF-36 questionnaire and monitor safety and health status. The study aims to develop a predictive score based on these observations, with total participation lasting one year.
CONDITIONS
Brief Title
PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy > 1 year
- Need to start prolonged glucocorticoid therapy at a dose of 15 mg/day or higher for an inflammatory rheumatic disease
- Starting treatment or experiencing a relapse
- Planned glucocorticoid treatment duration longer than 3 months
You will not qualify if you...
- Unable to give consent
- Previous corticosteroid therapy at more than 5 mg per day within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who undergo routine care with prolonged glucocorticoid therapy are observed to assess complications and quality of life outcomes.
Regular assessments during treatment period
Trial Site Locations
Total: 11 locations
1
CHU d'Angers
Angers, France, 49933
Actively Recruiting
2
CHRU de Brest
Brest, France, 29609
Actively Recruiting
3
CHD Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
4
CH Le Mans
Le Mans, France, 72000
Actively Recruiting
5
CH des Pays de Morlaix
Morlaix, France, 29672
Actively Recruiting
6
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
7
CHR d'Orléans
Orléans, France, 45067
Not Yet Recruiting
8
<CHU de Poitiers
Poitiers, France
Actively Recruiting
9
CHIC Quimper
Quimper, France, 29000
Actively Recruiting
10
Clinique St Exupéry
Toulouse, France
Actively Recruiting
11
CHU de Tours
Tours, France, 37044
Actively Recruiting
Research Team
D
Dewi GUELLEC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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