Inflammatory RheumatismPRODIGIOUSNCT04664465
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
An observational study of Inflammatory Rheumatism and Polymyalgia Rheumatica, run by University Hospital, Brest at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis
- How many people
- 300 participants
- Where
- 12 sitesFrance
- Study dates
- 18 Mar 2021to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.
Who may be able to join
- 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.
Who cannot join
- Unable to consent.
- Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU d'Angers
Angers, 49933
CHRU de Brest
Brest, 29609
CHD Vendée
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans, 72000
CH des Pays de Morlaix
Morlaix, 29672
CHU de Nantes - Service de Médecine interne
Nantes, 44093
CHU de Nantes - Service de Rhumatologie
Nantes, 44093
CHR d'Orléans
Orléans, 45067
<CHU de Poitiers
Poitiers
CHIC Quimper
Quimper, 29000
Clinique St Exupéry
Toulouse
CHU de Tours
Tours, 37044
About this study
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.
- Conditions
- Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis, Systemic Autoimmune Disease
- Medical subject headings
- Rheumatic Fever, Polymyalgia Rheumatica, Giant Cell Arteritis, Myositis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
Quality of life assessed through SF-36
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start18 Mar 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory RheumatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664465
- Sponsor's protocol ID
- 29BRC20.0274
- Acronym
- PRODIGIOUS
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
- ClinicalTrials.gov ID
- NCT04664465
- Acronym / sponsor ID
- PRODIGIOUS / 29BRC20.0274
- Conditions
- Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis, Systemic Autoimmune Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to consent.
- Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically relevant complication of glucocorticoid therapy
Time frame: 1 year
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).
1 secondary outcome
Quality of life assessed through SF-36
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Rheumatism and Polymyalgia Rheumatica, run by University Hospital, Brest at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically relevant complication of glucocorticoid therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.