STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
Not applicable · Testing MRI · 17 sites · University Hospital, Clermont-Ferrand
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MRI (a radiation) to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease, Calprotectin and MRI.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 3 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 180 participants are expected to take part.
- Start date: 2022-03-21.
- Main results expected around 2027-03-21 (estimate from the record).
- 17 study sites listed (1 marked recruiting) in France.
Main thing being measured
- Proportion of months spent in clinical remission (Between week 24 and week 76.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Calprotectin; MRI |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Enrollment | 180 (estimated) |
| Start date | 2022-03-21 |
| Primary completion (est.) | 2027-03-21 |
| First posted | 2021-07-22 |
| Last updated | 2026-07-30 |
| 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 |
Interventions
- MRI (Radiation)
2 additional MRI will be done for the CALM + MRI group
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * Severe obstructive symptoms * Uncontrolled intra-abdominal abscess * Isolated anoperineal lesions * Prevention of postoperative endoscopic recurrence * Temporary or definitive ostomy * Total colectomy * Contraindication to MRI * Pregnant or breastfeeding women * Protected adults (curatorship, guardianship, saving justice) * Refusal of participation
Locations (17)
| Site | City | Country | Site status |
|---|---|---|---|
| Amiens university hospital | Amiens | France | Not yet recruiting |
| Aurillac Hospital | Aurillac | France | Not yet recruiting |
| Bayonne hospital | Bayonne | France | Not yet recruiting |
| Bordeaux university hospital | Bordeaux | France | Not yet recruiting |
| Chambery Hospital | Chambéry | France | Not yet recruiting |
| Clermont-Ferrand University hospital | Clermont-Ferrand | France | Recruiting |
| Grenoble University Hospital | Grenoble | France | Not yet recruiting |
| Issoire Hospital | Issoire | France | Not yet recruiting |
| LILLE university hospital | Lille | France | Not yet recruiting |
| Lyon Hospital, Hospices civils de Lyon | Lyon | France | Not yet recruiting |
| Montluçon Hospital | Montluçon | France | Not yet recruiting |
| Montpellier University hospital | Montpellier | France | Not yet recruiting |
| Nancy University hospital | Nancy | France | Not yet recruiting |
| Nice University hospital | Nice | France | Not yet recruiting |
| Rennes University Hospital | Rennes | France | Not yet recruiting |
| Saint Etienne University Hospital | Saint-Etienne | France | Not yet recruiting |
| Thiers Hospital | Thiers | France | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.