Studies why some people with Crohn's or colitis do not respond to first treatment
Collects samples from adults with Crohn's disease or ulcerative colitis starting standard biological treatment.
Key facts
- Who runs it
- Central Hospital, Nancy, France
- Where
- Vandœuvre-lès-Nancy, FranceSee the site
- Trial code
- Registry title
- Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 14 Jun 2023
- Expected to end
- 1 Aug 2030
- Type of study
- Interventional
- Treatments tested
- Samples
- Record updated
- 6 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe Crohn's disease or ulcerative colitis who are about to start a biological or small molecule drug.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Crohn's disease or ulcerative colitis for at least 3 months, with moderate to severe disease activity (ulcerative colitis: Mayo Score ≥ 6 with endoscopy score of ≥ 2; Crohn's disease: CDAI score between 220 and 450).
- Earlier treatment
- A doctor must plan to start a biological or small molecule drug (anti-TNF, anti-IL 21/23, anti-integrin or JAK-inhibitor). People on corticosteroids need a stable dose of 20 mg prednisone or less for at least 3 weeks before the start.
Main reasons for not taking part
- Other types of colitis (indeterminate, microscopic, ischaemic, infectious, radiation)
- Anaemia (haemoglobin < 10g/dl) at the start
- Bleeding disorders, or a reason that rules out colonoscopy
- Surgery planned for ulcerative colitis
- Pregnant, giving birth or breastfeeding women, minors, and people under legal protection or unable to give consent
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
- Person informed about study organization and having signed the informed consent
- Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum disease duration of 3 months
- Moderate to severe disease activity; UC : Mayo Score ≥ 6 including endoscopy score of ≥ 2; CD : CDAI score betwenn 220 and 450 (inclusive)
- Indication to start any biological or small molecule agent (anti-TNF, anti-IL 21/23, anti-integrin and JAK-inhibitors)
- In case of treatment with corticosteroid : stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
- Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
- Person affiliated to or beneficiary of a social security plan
Who cannot take part
- Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
- Absolute contraindications to colonoscopy procedures, complication during previous endoscopy
- Indication for surgery for UC
- Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
- Treatment with > 20 mg prednisone within 3 weeks prior to baseline
- Bleeding disorders
- Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1
- Anaemia (haemoglobbin < 10g/dl) at baseline
- Subject unable to comply with the study procedures
- Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:; Pregnant, parturient or breastfeeding woman; Minor person (non-emancipated); Adult person under legal protection (any form of public guardianship); Adult person incapable of giving consent and not under legal protection
Where in France
- CHRU of NANCYVandœuvre-lès-Nancy, FranceContact: Laurent PEYRIN-BIROULET, MDTaking people
About the trial
What the trial wants to find out
Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\ie colitis (UC) and Crohn s disease (CD). The diseases differ in anatomical distribution, with continuous, uniform inflammation restricted to the colon in UC, and multifocal inflammation extended throughout the entire gastrointestinal tract from mouth to anus in CD. Clinical symptoms of IBD may include bloody stools, abdominal pain, fatigue, diarrhoea, fever and weight loss. Extra-intestinal symptoms occurring in up to 40% of patients, e.g. anaemia, skin lesions (e.g. erythema nodosum, pyoderma), arthritis and uveitis, and other complications directly related to the disease organ, such as fistula in CD are considered to reflect an overwhelming systemic inflammatory state. Disease onset typically manifests at age 15-35 years, men and women are almost equally affected. In addition, paediatric forms of IBD that often represent complex, se\/ere monogenic forms of the disease, are seen. The incidence rates of IBD in Europe are about 6.3 (CD) and 11.8 (UC) per 100.000 persons. With growing incidence rates and overall reduced mortality the lifetime prevalence of IBD is expected to rise. The estimated lifetime prevalence of 0.3%-0.5% of the European population corresponds to estimates of 1.5-2 million patients with IBD.
Read full original descriptionShow less
Appropriate selection of therapies and their timing of introduction (decision support) in the course of IBD will be essential to reach a higher degree of disease control (across patients and within individual patients) than it is achie\led today. In many instances, comparati\ie data is missing and combinations or sequential therapies are not developed. In summary, despite some treatment successes, major challenges remain.
The investigators have decided to include patients with inflammatory bowel disease (IBD) in which targeted therapies are administered as part of standard helathcare and which aims at identifiyng solid biomarker signatures as well as molecular pathways and mechanisms linked to response and non-response to therapy. Choice od medications (which are all approved for first line use) is by treating physicians. All follow-up procedures are according to standards of care.
The group in the trial
- SamplesOther group
The intervention is to collect blood; urine; saliva and stool samples but also mucosal biopsies at each protocol visits (baseline and follow up visits).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Molecular Mechanisms of Non-response to Treatments, Relapses and Remission in Ulcerative Colitis and Crohn's Disease Patients Receiving First Time Standard of Care Biological Treatment
- Plain-language title
- Studies why some people with Crohn's or colitis do not respond to first treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 May 2025