Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Central Hospital, Nancy, France|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Stefan MD SCHREIBER, PhD|
|Principal Investigator Affiliation||Christian Albrechts Universität|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ulcerative Colitis, Inflammatory Bowel Diseases|
: UC patients
All patients with an established ulcerative colitis
Procedure: - Procedure: endoscopic biopsy
Procedure: - Blood sampling
Procedure: - stool sampling
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.