Actively Recruiting
Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
Led by Central Hospital, Nancy, France · Updated on 2025-05-06
100
Participants Needed
1
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years of age or older at the time of consent
- Signed informed consent
- Established diagnosis of Crohn's disease or ulcerative colitis for at least 3 months
- Moderate to severe disease activity (UC: Mayo Score 63; 6 with endoscopy score 63; 2; CD: CDAI score 220 to 450)
- Indication to start any approved biological or small molecule agent (anti-TNF, anti-IL 21/23, anti-integrin, JAK-inhibitors)
- Stable corticosteroid dose (64; 20 mg prednisone) for at least 3 weeks before baseline if applicable
- Indication for colonoscopy to assess disease activity per standard care
- Affiliated with or beneficiary of a social security plan
You will not qualify if you...
- Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, or radiation colitis
- Absolute contraindications to colonoscopy or complications from previous endoscopy
- Bleeding disorders
- Indication for surgery for ulcerative colitis
- Use of rectal topical therapy (enemas or suppositories) within 2 weeks before baseline
- Treatment with prednisone above 20 mg within 3 weeks before baseline
- Anemia with hemoglobin below 10 g/dL at baseline
- Unable to comply with study procedures
- Pregnant, breastfeeding, or parturient women
- Minors who are not legally emancipated
- Adults under legal protection or unable to give consent
- Persons deprived of liberty by judicial or administrative decisions
- Persons under psychiatric care as specified by law
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHRU of Nancy
Vandœuvre-lès-Nancy, CHRU de Nancy, France, 54511
Actively Recruiting
Research Team
L
Laurent PEYRIN-BIROULET, PU-PH
CONTACT
M
Marine BECK, CPM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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