A multicentre prospective longitudinal observational study to evaluate biomarkers and mechanistic principles in moderate to severe ulcerative colitis (UC) patients treated with different targeted therapies. - ImmUniverse UC

Innovative Medecines Initiative (IMI) (EURICE)0 个研究点目标入组 45 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•Prescription of a targeted therapy, choice is by treating physician:
•- Anti-TNF and, or Anti-IL 12/23 and, or Anti-integrin and, or JAK-inhibitors.
•1. Male and female patients >= 18 years of age (at the time of signing the
•Informed Consent)
•2. Signed written Informed Consent
•3. Established diagnosis of ulcerative colitis with a minimum disease duration
•of 3 months
•4. Moderate to severe active UC, defined by Mayo Score >= 6 including endoscopy
•score of >= 2
•5. Indication to start any biological or small molecule agent (anti-TNF, anti-
•IL12/23, anti-integrin and JAK-inhibitors)
•6. In case of treatment with corticosteroid: stabile dose for at least 3 weeks
•prior to baseline, dosage <= 20 mg prednisone
•7. Indication for colonoscopy for the assessment of disease activity as for
•standards of care and current guidelines
•8. Able to comply with the study procedures

•1. Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis,
•infectious colitis, radiation colitis
•2. Absolute contraindications to colonoscopy procedures, complication during
•previous endoscopy
•3. Bleeding disorders
•4. Indication for surgery for UC
•5. Legal incapacity
•6. Rectal topical therapy (enemas or suppositories) <= 2 weeks prior to baseline
•7. Treatment with > 20 mg prednisone within 3 weeks prior to baseline
•8. anaemia (haemoglobin < 10 g/dl) at baseline
•9. Pregnant or breastfeeding women
•10. 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

发起方

Innovative Medecines Initiative (IMI) (EURICE)