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New treatment option for Crohn Disease
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
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Severe obstructive symptoms
- Uncontrolled intra-abdominal abscess
- Isolated anoperineal lesions
- Prevention of postoperative endoscopic recurrence
- Temporary or definitive ostomy
- Total colectomy
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Aurillac, France
- Bayonne, France
- Bordeaux, France
- Chambéry, France
- Clermont-Ferrand, France
- Grenoble, France
- Issoire, France
- Lille, France
- Lyon, France
- Montluçon, France
- Montpellier, France
- Nancy, France
- Nice, France
- Rennes, France
- Saint-Etienne, France
- Thiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Aurillac, France; Bayonne, France; Bordeaux, France; Chambéry, France; Clermont-Ferrand, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.