Crohn DiseaseDeeperNCT04973423
STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
A study testing MRI in people with Crohn Disease and Calprotectin, run by University Hospital, Clermont-Ferrand at 17 sites in France.
Trial summary
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Calprotectin, MRI
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 17 sitesFrance
- Study dates
- 21 Mar 2022to 21 Aug 2027
- Phase
- Interventional
- 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
- Adult Crohn's disease (age ≥ 18 years)
- Symptomatic with Crohn's disease activity index (CDAI)> 150
- Presence of objective signs of inflammatory activity (fecal calprotectin> 250 AND sign of MRI activity)
- Requiring treatment with biotherapy according to the investigator
- Able to give informed consent to participate in research
- Affiliation to a Social Security scheme.
Who cannot join
- Severe obstructive symptoms
- Uncontrolled intra-abdominal abscess
- Isolated anoperineal lesions
- Prevention of postoperative endoscopic recurrence
- Temporary or definitive ostomy
- Total colectomy
Show all 10Show fewer
- Contraindication to MRI
- Pregnant or breastfeeding women
- Protected adults (curatorship, guardianship, saving justice)
- Refusal of participation
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
Amiens university hospital
Amiens
MAthurin FUMERY
- Not yet recruiting
Aurillac Hospital
Aurillac
Clément PASTAUD
- Not yet recruiting
Bayonne hospital
Bayonne
Félix GOUTORBE
- Not yet recruiting
Bordeaux university hospital
Bordeaux
David LAHARIE
- Not yet recruiting
Chambery Hospital
Chambéry
Christophe Allimant
- Recruiting
Clermont-Ferrand University hospital
Clermont-Ferrand
Anthony BUISSON
- Not yet recruiting
Grenoble University Hospital
Grenoble
Nicolas MATHIEU
- Not yet recruiting
Issoire Hospital
Issoire
Camille Sautel
- Not yet recruiting
LILLE university hospital
Lille
Maria NACHURY
- Not yet recruiting
Lyon Hospital, Hospices civils de Lyon
Lyon
Stéphane NANCEY
- Not yet recruiting
Montluçon Hospital
Montluçon
Cédric DURON
- Not yet recruiting
Montpellier University hospital
Montpellier
Romain ALTWEGG
- Not yet recruiting
Nancy University hospital
Nancy
Laurent PEYRIN-BIROULET
- Not yet recruiting
Nice University hospital
Nice
Xavier HEBUTERNE
- Not yet recruiting
Rennes University Hospital
Rennes
Guillaume BOUGUEN
- Not yet recruiting
Saint Etienne University Hospital
Saint-Etienne
Xavier ROBLIN
- Not yet recruiting
Thiers Hospital
Thiers
Julien SCANZI
About this study
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark.
Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.
Read the detailed description
This is a randomized, open-label controlled study comparing two therapeutic strategies in patients with CD (see inclusion criteria) starting biotherapy. Randomization, by minimization (Stata version 15), will be stratified by center, by biotherapy line and on the location of the disease: MC colic isolated (L2 according to the Montreal classification) vs. Ileal or ileocolic MC (L1 + L3), for a maximum of L1 + L3 patients of 70%.
The reference arm will be based on that of the CALM study, i.e. regular follow-up (S0, S12, S24, S52, S76, S100, S124 and S152) with therapeutic intensification in the absence of at least one criterion among CDAI <150, CRP <5 or fecal calprotectin <250. After checking the inclusion criteria, the patients will be included and randomized. The initial choice of biotherapy, therapeutic intensifications (dose increase, interval reduction, treatment change) and treatment sequences will be based on the French consensus of 2020. MRI will be performed in all patients at weeks 0, 76 and 152. In the MRI arm, an additional MRI will be performed at W24 and W52 with therapeutic intensification at W24, W52 and W76 in the presence of residual MRI activity. Patients will be followed for 152 weeks (≈ 3 years). In the event of a missing examination (calprotectin or MRI), the intensification will be carried out or not with the available data. Therefore, the analysis will be performed by intention to treat (ITT). Patients will be given a symptom calendar (abdominal pain score (between 0 = no pain and 3 = severe pain) and number of stools). Each month without data (lost to follow-up) will be considered as in the absence of clinical remission without corticosteroids (ITT). The fecal calprotectin dosage will be standardized and performed with the same test in all patients. Therapeutic intensification based on MRI will be carried out after a centralized review. The secondary endpoints (response and transmural healing, Lémann index) will be centrally blinded in the study arm to avoid any evaluation bias.
- Conditions
- Crohn Disease, Calprotectin, MRI
- Being tested
- MRI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
2 additional MRI will be done for the CALM + MRI group
| Study group | Role | What they receive |
|---|---|---|
| CALM | No intervention | Tight control of inflammatory activity by calprotectin. |
| CALM + IRM | Other | Tight control of inflammatory activity by calprotectin associated with transmural evaluation. Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of months spent in clinical remission
Proportion of months (4 week period) spent in clinical remission without corticosteroids according to PRO-2 (<3 very soft or watery stools per day and no moderate to severe abdominal pain).
Measured: Between week 24 and week 76.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start21 Mar 2022
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973423
- Sponsor's protocol ID
- PHRC IR 2020 BUISSON
- Acronym
- Deeper
- Status last verified
- May 2026
- First submitted
- 13 Jul 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
- ClinicalTrials.gov ID
- NCT04973423
- Acronym / sponsor ID
- Deeper / PHRC IR 2020 BUISSON
- Conditions
- Crohn Disease, Calprotectin, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Aug 2027 (estimated)
- First posted
- 22 Jul 2021 (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.
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark.
Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.
Detailed description
This is a randomized, open-label controlled study comparing two therapeutic strategies in patients with CD (see inclusion criteria) starting biotherapy. Randomization, by minimization (Stata version 15), will be stratified by center, by biotherapy line and on the location of the disease: MC colic isolated (L2 according to the Montreal classification) vs. Ileal or ileocolic MC (L1 + L3), for a maximum of L1 + L3 patients of 70%.
The reference arm will be based on that of the CALM study, i.e. regular follow-up (S0, S12, S24, S52, S76, S100, S124 and S152) with therapeutic intensification in the absence of at least one criterion among CDAI <150, CRP <5 or fecal calprotectin <250. After checking the inclusion criteria, the patients will be included and randomized. The initial choice of biotherapy, therapeutic intensifications (dose increase, interval reduction, treatment change) and treatment sequences will be based on the French consensus of 2020. MRI will be performed in all patients at weeks 0, 76 and 152. In the MRI arm, an additional MRI will be performed at W24 and W52 with therapeutic intensification at W24, W52 and W76 in the presence of residual MRI activity. Patients will be followed for 152 weeks (≈ 3 years). In the event of a missing examination (calprotectin or MRI), the intensification will be carried out or not with the available data. Therefore, the analysis will be performed by intention to treat (ITT). Patients will be given a symptom calendar (abdominal pain score (between 0 = no pain and 3 = severe pain) and number of stools). Each month without data (lost to follow-up) will be considered as in the absence of clinical remission without corticosteroids (ITT). The fecal calprotectin dosage will be standardized and performed with the same test in all patients. Therapeutic intensification based on MRI will be carried out after a centralized review. The secondary endpoints (response and transmural healing, Lémann index) will be centrally blinded in the study arm to avoid any evaluation bias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALM | No intervention | –Tight control of inflammatory activity by calprotectin. |
| CALM + IRM | Other | Radiation: MRITight control of inflammatory activity by calprotectin associated with transmural evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult Crohn's disease (age ≥ 18 years)
- Symptomatic with Crohn's disease activity index (CDAI)> 150
- Presence of objective signs of inflammatory activity (fecal calprotectin> 250 AND sign of MRI activity)
- Requiring treatment with biotherapy according to the investigator
- Able to give informed consent to participate in research
Key exclusion criteria (10 listed)
- Severe obstructive symptoms
- Uncontrolled intra-abdominal abscess
- Isolated anoperineal lesions
- Prevention of postoperative endoscopic recurrence
- Temporary or definitive ostomy
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 |
|---|---|---|
| MRI2 additional MRI will be done for the CALM + MRI group | Radiation | CALM + IRM |
Primary outcome
Proportion of months spent in clinical remission
Time frame: Between week 24 and week 76.
Proportion of months (4 week period) spent in clinical remission without corticosteroids according to PRO-2 (<3 very soft or watery stools per day and no moderate to severe abdominal pain).
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 30 Jul 2026.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Crohn Disease and Calprotectin, run by University Hospital, Clermont-Ferrand at 17 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 6 inclusion and 10 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of months spent in clinical remission (time frame: Between week 24 and week 76.). 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 30 Jul 2026.