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PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04664465
Acronym
PRODIGIOUS
Enrollment
300
Registered
2020-12-11
Start date
2021-03-18
Completion date
2026-09-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA Associated Vasculitis, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, Inflammatory Rheumatism, Polymyalgia Rheumatica, Systemic Autoimmune Disease

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Clinically relevant complication of glucocorticoid therapy1 yearThe 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

MeasureTime frame
Quality of life assessed through SF-361 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026