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.
- Conditions
- bowel inflammation10017969immune disease
- Registration Number
- NL-OMON52173
- Lead Sponsor
- Innovative Medecines Initiative (IMI) (EURICE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method