NCT04664465 PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
| NCT ID | NCT04664465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Inflammatory Rheumatism |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-03-18 |
| Primary Completion | 2026-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-03-18 with a primary completion date of 2026-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04664465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Inflammatory Rheumatism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04664465 currently recruiting?
Yes, NCT04664465 is actively recruiting participants. Contact the research team at dewi.guellec@chu-brest.fr for enrollment information.
Where is the NCT04664465 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, La Roche-sur-Yon, France, Le Mans, France and 7 additional locations.
Who is sponsoring the NCT04664465 clinical trial?
NCT04664465 is sponsored by University Hospital, Brest. The trial plans to enroll 300 participants.