PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS (NCT04664465) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
France300 participantsStarted 2021-03-18
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at glucocorticoid toxicity in conditions like mine — could you help me understand which complications they're tracking, and how likely those complications are given my specific diagnosis and the glucocorticoid dose I'd be taking?
2Since this trial is no longer actively enrolling, is there any related study or registry that's still open that I could participate in to help monitor my own risks from glucocorticoid treatment?
3This trial involves several different diseases, including polymyalgia rheumatica, giant cell arteritis, and vasculitis — does the risk profile for glucocorticoid side effects differ meaningfully between those conditions, and how does that apply to my specific situation?
4Since the trial is focused on predicting complications rather than testing a new treatment, what would the findings from a study like this actually mean for how my glucocorticoid therapy is managed day-to-day?
5Are there already known predictors of glucocorticoid toxicity that my care team uses to assess my risk, and would participating in or reviewing data from a study like this change anything about how closely I'd be monitored?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically relevant complication of glucocorticoid therapy