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

Recruiting

Conditions: K51.9
Ulcerative colitis, unspecified

Registration Number: DRKS00023031

Lead Sponsor: niversitätskliniikum Schleswig-Holstein, Campus Kiel Klinik für Innere Medizin I für die deutschen Partner der multizentrischen Studie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

1. Signed written Informed Consent
2. Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
3. Moderate to severe active UC, defined by Mayo Score = 6 including endoscopy score of = 2
4. Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
5. In case of treatment with corticosteroid: stabile dose for at least 3 weeks prior to baseline, dosage = 20 mg prednisone
6. Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
7. Able to comply with the study procedures

Exclusion Criteria

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response at week 14, defined as overall Mayo score of 2 or smaller with Mayo endoscopy score of 0 or 1 (without friability), and bleeding subscore of 0

Secondary Outcome Measures

Name	Time	Method
• deep clinical remission (Mayo Score 0-1 with SF =1 and RB = 0)<br>• mucosal healing (Mayo ES = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1).<br>• symptomatic remission assessed by patient-reported outcome PRO 2 (SF 0-1 and RB 0)<br>• disease progression e.g. flares <br>• complications until week 52<br>o hospitalizations due to UC<br>o treatment intensification including introduction of toxic long-term therapies (i.e. systemic glucocorticoids)<br>o new stenosis<br>o new fistula<br>o new development of PSC<br>o infections<br>o intestinal surgery<br>