Understanding why some patients with inflammatory bowel disease don't respond to therapy
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
This study is trying to find out why some people with inflammatory bowel disease, like Crohn's and ulcerative colitis, don't respond to treatment so that doctors can improve care for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Vandœuvre-lès-Nancy, CHRU de Nancy) |
| Trial ID | NCT05733845 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the molecular mechanisms behind the lack of response to therapy in patients suffering from inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis. It will involve collecting samples from patients who have been diagnosed with these conditions and are experiencing moderate to severe disease activity. The research will focus on identifying biomarkers that could explain the variability in treatment responses among patients. By understanding these mechanisms, the study hopes to improve therapeutic strategies for individuals with IBD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Crohn's disease or ulcerative colitis and moderate to severe disease activity.
Not a fit: Patients with indeterminate colitis or other specific types of colitis such as microscopic or ischemic colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more personalized treatment options for patients with inflammatory bowel disease, enhancing their chances of effective therapy.
How similar studies have performed: While the specific molecular mechanisms of non-response in IBD are still being explored, similar studies have shown promise in identifying biomarkers for treatment response in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis * Absolute contraindications to colonoscopy procedures, complication during previous endoscopy * Bleeding disorders * 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 * 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 * Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Where this trial is running
Vandœuvre-lès-Nancy, CHRU de Nancy
- CHRU of Nancy — Vandœuvre-lès-Nancy, CHRU de Nancy, France (Recruiting)
Study contacts
- Principal investigator: Laurent PEYRIN-BIROULET — CHRU of Nancy, Hepatogastroenterology Department
- Study coordinator: Laurent PEYRIN-BIROULET, PU-PH
- Email: peyrinbiroulet@gmail.com
- Phone: 03.83.15.36.61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.