Predicting complications from glucocorticoid therapy in inflammatory rheumatic diseases
PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
University Hospital, Brest · NCT04664465
This study is trying to create a tool to help doctors predict complications in people with inflammatory rheumatic diseases who are on long-term glucocorticoid therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 11 sites (Angers and 10 other locations) |
| Trial ID | NCT04664465 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive tool for assessing the risk of complications from prolonged glucocorticoid therapy in patients with inflammatory rheumatic disorders. By analyzing routine clinical, biological, and DXA baseline characteristics, the study seeks to identify factors that can predict clinically relevant complications within one year. The findings could help tailor treatment decisions for patients requiring long-term glucocorticoid therapy, enhancing patient care and outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with inflammatory rheumatic diseases who are starting prolonged glucocorticoid therapy at a dosage of 15 mg/day or higher.
Not a fit: Patients who have received significant corticosteroid therapy in the last three months or are unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that minimize complications for patients on glucocorticoid therapy.
How similar studies have performed: While there may be studies on glucocorticoid therapy, this specific predictive approach appears to be novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Angers and 10 other locations
- CHU d'Angers — Angers, France (RECRUITING)
- CHRU de Brest — Brest, France (RECRUITING)
- CHD Vendée — La Roche-sur-Yon, France (RECRUITING)
- CH Le Mans — Le Mans, France (RECRUITING)
- CH des Pays de Morlaix — Morlaix, France (RECRUITING)
- CHU de Nantes — Nantes, France (RECRUITING)
- CHR d'Orléans — Orléans, France (NOT_YET_RECRUITING)
- <CHU de Poitiers — Poitiers, France (RECRUITING)
- CHIC Quimper — Quimper, France (RECRUITING)
- Clinique St Exupéry — Toulouse, France (RECRUITING)
- CHU de Tours — Tours, France (RECRUITING)
Study contacts
- Study coordinator: Dewi GUELLEC
- Email: dewi.guellec@chu-brest.fr
- Phone: 02-98-34-72-64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis, Systemic Autoimmune Disease