Idiopathic Retroperitoneal FibrosisPhase 4METRONCT05428826
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis
A Phase 4 study testing Prednisone in people with Idiopathic Retroperitoneal Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
Trial summary
Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Retroperitoneal Fibrosis
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 15 sitesFrance
- Study dates
- 25 Nov 2022to 25 Nov 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:
- Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND
- Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan
Who cannot join
- Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled
- Contraindication to perform FDG-PET/CT,
- Contraindication to perform CT scan with injection of contrast agent,
- Contraindication to treatment by prednisone
- Active infection
- Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,
Show all 15Show fewer
- Active or history of malignancy in last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment,
- Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,
- Live vaccination received from 4 weeks before inclusion,
- Inhaled glucocorticoids (except for patients with documented asthma),
- Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,
- Pregnancy or breastfeeding,
- Non-affiliation to a social security regime,
- Subject deprived of freedom, subject under a legal protective measure
- Refusal to participate
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 12 recruiting
- Recruiting
Médecine Interne
Agen, France, 47000
RORIZ Mélanie, rorizm@ch-agen-nerac.fr
- Recruiting
Médecine interne et maladies infectieuses - GH Sud Haut Lévêque
Bordeaux, 33604
VIALLARD Jean-François, jean-francois.viallard@chu-bordeaux.fr
- Recruiting
Médecine interne - Ambroise Paré
Boulogne-Billancourt, 92100
KAHN Jean-Emmanuel, jean-emmanuelle.kahn@aphp.fr
- Recruiting
Médecine interne
Brest, France, 29200
POGIOSSIAN Alexan, alexan.pogossian@chu-brest.fr
- Recruiting
Médecine interne - Henri-Mondor
Créteil, 94000
MICHEL Marc, marc.michel2@aphp.fr
- Recruiting
Médecine interne et immunologie clinique - Dijon
Dijon, 21000
BONNOTTE Bernard, bernard.bonnotte@chu-dijon.fr
- Active, not recruiting
Médecine interne - Lille
Lille, 59000
- Recruiting
Médecine Interne - La Timone
Marseille, 13005
SCHLEINITZ Nicolas, nicolas.schleinitz@ap-hm.fr
- Recruiting
Médecine interne - Saint Antoine
Paris, 75012
FAIN Olivier, olivier.fain@aphp.fr
- Recruiting
Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière
Paris, 75013
CACOUB Patrice, patrice.cacoub@aphp.fr
- Recruiting
Médecine interne - Cochin
Paris, 75014
MOUTHON Luc, luc.mouthon@cch.aphp.fr
- Recruiting
Médecine vasculaire - HEGP
Paris, 75015
MIRAULT Tristan, tristan.mirault@aphp.fr
- Recruiting
Médecine Interne - Bichat
Paris, 75018
SACRE Karim, karim.sacre@aphp.fr
- Active, not recruiting
Néphrologie - Bichat
Paris, 75018
- Active, not recruiting
Médecine interne - Delafontaine
Saint-Denis, 93200
About this study
Official title: Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study
Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.
Read the detailed description
At baseline visit: Eligible patients will be screen during a standard visit care (consultation or hospitalization). A clinical examination, an abdominal CT scan, blood and urine biological tests will be performed.
At inclusion visit: After verification of inclusion and non inclusion criteria, if the patient meets the eligibility criteria, the investigator, will provide the patient with information and details regarding the trial. The consent is obtained and signed after a reflection period of 30 minutes.
The following procedure will be scheduled within 7 days:
- 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) (pregnancy test if mandatory)
- Specimens for the biocollection Patients with positive FDG PET/CT (hypermetabolism grade II or III) at M0 will receive oral steroids (prednisone) at 1mg/kg/day during 1 month and then the dose will be tapered to obtain <10mg/day at 6 months and <7,5mg/day at 9 months.
Patients with a negative FDG-PET/CT (hypermetabolism grade 0 or I) at M0 will be excluded of the study.
Follow-up visits : M6, M9,M12,M15,M21, relapse At M6, M12, and M15: During these visits clinical examination (blood pressure measurement, body temperature, heart rate, weight and clinical signs or symptoms related to IRF) will be performed. An abdominal CT scan may be performed as part of the care depending on the clinician's judgment. Glucocorticoid compliance and tapering, concomitant medications and adverse events (including serious cardiovascular adverse events) will be assessed and recorded. A nurse will collect blood and urine.
At M9, M21 or relapse : During these visits clinical examination, an abdominal CT scan, a FDG-PET/CT blood and urine biological tests will be performed.
At M9: The patients who failed to reach remission at M9 are considered as treatment failure and will be treated on best medical judgment by the investigator and excluded to the study. The patients who had a dose of prednisone ≥7,5mg / day at M9 will also be excluded to the study.
Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade 0 or I under a dose of prednisone <7,5mg / day will discontinue steroids treatment.
Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade II or III under a dose of prednisone <7,5mg / day will continue steroids treatment at the actual dose (medical judgment).
- Conditions
- Idiopathic Retroperitoneal Fibrosis
- Being tested
- Prednisone
- Keywords
- Steroid treatment
- Medical subject headings
- Retroperitoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
The primary endpoint is the cumulate IRF relapse rate 12 months after discontinuation of steroids.
The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):
- Clinical or biological criteria
- recurrent or new-onset disease related symptoms
- increase in C-reactive protein (CRP) >20mg/L without other cause
- And a Radiological criterion o increased of retroperitoneal fibrosis size as compared with the CT scan performed at remission.
The primary endpoint will be centrally adjudicated.
Measured: 12 months after discontinuation of steroids
Secondary outcomes (15)
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III),
Measured: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at diagnosis (M0)
Measured: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at diagnosis
Measured: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Visual grades of retroperitoneal fibrosis fluorodeoxyglucose uptake as compared to liver fluorodeoxyglucose uptake (which consist of one item that yields a score of 0 to 3) A 0 significate an lack of FDG binding and a 3 an FDG uptake greater than liver uptakesignificate.
Measured: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at remission (M9)
Measured: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake remission (M9)
Measured: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III)
Measured: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at M21
Measured: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at M21
Measured: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III)
Measured: between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at relapse
Measured: between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at relapse
Measured: between inclusion and 21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Diagnostic performance of SUVmax for the disease activity
Measured: 21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Diagnostic performance of MAV (area under the curve (AUC) and performance values for the Youden index) for the disease activity
Measured: 21 months after the inclusion
To compare at M21 the corticosteroids therapy - related adverse events between patients who continue or discontinue the treatment at M9.
Frequency of diabetes, severe infection, osteoporotic fracture and major cardiovascular events 12 months after remission (M21). Serious cardiovascular adverse events are defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death and will be assessed at M12,M15 and M21
Measured: 21 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start25 Nov 2022
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Retroperitoneal FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline DECHANET, Study chair, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428826
- Sponsor's protocol ID
- APHP210082
- Acronym
- METRO
- Status last verified
- May 2025
- First submitted
- 7 Jun 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study
- ClinicalTrials.gov ID
- NCT05428826
- Acronym / sponsor ID
- METRO / APHP210082
- Conditions
- Idiopathic Retroperitoneal Fibrosis
- Keywords
- Steroid treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2028 (estimated)
- First posted
- 23 Jun 2022 (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.
Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.
Detailed description
At baseline visit: Eligible patients will be screen during a standard visit care (consultation or hospitalization). A clinical examination, an abdominal CT scan, blood and urine biological tests will be performed.
At inclusion visit: After verification of inclusion and non inclusion criteria, if the patient meets the eligibility criteria, the investigator, will provide the patient with information and details regarding the trial. The consent is obtained and signed after a reflection period of 30 minutes.
The following procedure will be scheduled within 7 days:
- 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) (pregnancy test if mandatory)
- Specimens for the biocollection Patients with positive FDG PET/CT (hypermetabolism grade II or III) at M0 will receive oral steroids (prednisone) at 1mg/kg/day during 1 month and then the dose will be tapered to obtain <10mg/day at 6 months and <7,5mg/day at 9 months.
Patients with a negative FDG-PET/CT (hypermetabolism grade 0 or I) at M0 will be excluded of the study.
Follow-up visits : M6, M9,M12,M15,M21, relapse At M6, M12, and M15: During these visits clinical examination (blood pressure measurement, body temperature, heart rate, weight and clinical signs or symptoms related to IRF) will be performed. An abdominal CT scan may be performed as part of the care depending on the clinician's judgment. Glucocorticoid compliance and tapering, concomitant medications and adverse events (including serious cardiovascular adverse events) will be assessed and recorded. A nurse will collect blood and urine.
At M9, M21 or relapse : During these visits clinical examination, an abdominal CT scan, a FDG-PET/CT blood and urine biological tests will be performed.
At M9: The patients who failed to reach remission at M9 are considered as treatment failure and will be treated on best medical judgment by the investigator and excluded to the study. The patients who had a dose of prednisone ≥7,5mg / day at M9 will also be excluded to the study.
Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade 0 or I under a dose of prednisone <7,5mg / day will discontinue steroids treatment.
Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade II or III under a dose of prednisone <7,5mg / day will continue steroids treatment at the actual dose (medical judgment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisoneDose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:
- Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND
- Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan
Key exclusion criteria (15 listed)
- Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled
- Contraindication to perform FDG-PET/CT,
- Contraindication to perform CT scan with injection of contrast agent,
- Contraindication to treatment by prednisone
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisonePhase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months. | Drug | Prednisone |
Primary outcome
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
Time frame: 12 months after discontinuation of steroids
The primary endpoint is the cumulate IRF relapse rate 12 months after discontinuation of steroids. The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria): * Clinical or biological criteria * recurrent or new-onset disease related symptoms * increase in C-reactive protein (CRP) >20mg/L without other cause * And a Radiological criterion o increased of retroperitoneal fibrosis size as compared with the CT scan performed at remission. The primary endpoint will be centrally adjudicated.
15 secondary outcomes
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time frame: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time frame: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time frame: at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time frame: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time frame: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time frame: 9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time frame: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time frame: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time frame: 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time frame: between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time frame: between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time frame: between inclusion and 21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Time frame: 21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Time frame: 21 months after the inclusion
To compare at M21 the corticosteroids therapy - related adverse events between patients who continue or discontinue the treatment at M9.
Time frame: 21 months after the inclusion
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 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Retroperitoneal Fibrosis
Active, not recruitingObservational study
Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics
Retroperitoneal Sarcoma, Retroperitoneal Fibrosis
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
RecruitingObservational study
National Registry of IRPF in China
Idiopathic Retroperitoneal Fibrosis
RecruitingObservational study
A Prospective Cohort Study of IRPF in China
Idiopathic Retroperitoneal Fibrosis
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.
Aline DECHANET study chair
Assistance Publique - Hôpitaux de Paris (AP-HP)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Idiopathic Retroperitoneal Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 15 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 15 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Karim SACRE (01.40.25.60.19, karim.sacre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids. (time frame: 12 months after discontinuation of steroids). 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 25 May 2025.