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New treatment option for Crohn's Disease
Official title Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT05733845
What this study is testing
- What it's testing
- 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).
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
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, CHRU de Nancy, 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 Vandœuvre-lès-Nancy, CHRU de Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.