ClinicalTrials.gg
Active, not recruitingNCT04664465PRODIGIOUSUpdated Jun 12, 2026

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

An observational study in Inflammatory Rheumatism, Polymyalgia Rheumatica and Giant Cell Arteritis, sponsored by University Hospital, Brest. Active, not recruiting at 12 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Rheumatism
  • Polymyalgia Rheumatica
  • Giant Cell Arteritis
  • Idiopathic Inflammatory Myopathies
  • ANCA Associated Vasculitis
  • Systemic Autoimmune Disease
03

In context

Rheumatic Fever

55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 26 observational studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 1 year.
  • Indication to initiate prolonged 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

Exclusion Criteria:

  • Unable to consent.
  • Previous therapy in the last 3 months at a significant dosage (> 5 mg per day).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinically relevant complication of glucocorticoid therapy

    The 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).

    Time frame: 1 year

Secondary outcomes

  1. Quality of life assessed through SF-36

    Time frame: 1 year

07

Study locations

12 sites
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

Time frame: Data will be available beginning three years and ending five years following the publication

Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04664465
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Mar 18, 2021
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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