UCRecruiting
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
Observational · No treatment assigned · 1 site · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis and Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Male and female patients ≥ 18 years of age (at the time of signing the ICF)
- Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
- Moderate to severe active UC defined by Mayo Score ≥ 6
Plus 7 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 95 participants are expected to take part.
- Start date: 2022-07-28.
- Main results expected around 2027-09-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- The percentage of subjects who achieve clinical response at week 14. (The percentage of subjects who achieve clinical response at week 14)
In the researchers’ words
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis; Inflammatory Bowel Diseases |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 95 (estimated) |
| Start date | 2022-07-28 |
| Primary completion (est.) | 2027-09-09 |
| First posted | 2022-07-13 |
| Last updated | 2025-05-06 |
| Official title | A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies |
| ClinicalTrials.gov ID | NCT05456893 |
Interventions
- Procedure: endoscopic biopsy (Procedure)
Per-endoscopic biopsies - Blood sampling (Procedure)
Blood sampling - stool sampling (Procedure)
stool sampling
Full eligibility criteria (from the record)
Inclusion Criteria: * Male and female patients ≥ 18 years of age (at the time of signing the ICF) * Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months * Moderate to severe active UC defined by Mayo Score ≥ 6 * Moderate to severe active UC defined by endoscopy score of ≥2 * Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, 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 an endoscopy for the assessment of disease activity as for standards of care and current guidelines * Able to comply with the study procedures * Person affiliated to or beneficiary of a social security plan * Person informed about study organization and able to sign informed consent form Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis * Absolute contraindications to endoscopy procedures or 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 (haemoglobin < 10 g/dl) at baseline * Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Central Hospital | Nancy, Lorraine | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.