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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52173

Enrollment

Registered

2021-05-19

Start date

2022-01-04

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel inflammation immune disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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) 20 mg prednisone within 3 weeks prior to baseline 8. anaemia (haemoglobin

Design outcomes

Primary

Measure	Time frame
• Remission defined as a total Mayo score of 2 or less with a Mayo endoscopy score of 0 or 1 (without friability) and a bleeding score of 0 at week 14. • Clinical response at week 14 defined as total Mayo score of 2 or less with Mayo endoscopy score of 0 or 1 (without brittleness) and bleeding score of 0 The clinical response is divided into four subcategories: • "Superresponder": Meets clinical response criteria at week 14 • Responder: Mayo score: 50% reduction / >= 3 improvement from baseline, but does not meet the criteria for remission; endoscopic Mayo: Does not meet the criteria for clinical response, but shows a reduction in Mayo ES • Partial Responder: Mayo score: reduction to 30%, endoscopic Mayo: no formal improvement from Mayo ES but slight improvement in general physician assessment. • Non Responder: Reduction of less than 30% and no improvement in overall assessment at endoscopy	—

Measure

Time frame

• Remission defined as a total Mayo score of 2 or less with a Mayo endoscopy score of 0 or 1 (without friability) and a bleeding score of 0 at week 14. • Clinical response at week 14 defined as total Mayo score of 2 or less with Mayo endoscopy score of 0 or 1 (without brittleness) and bleeding score of 0 The clinical response is divided into four subcategories: • "Superresponder": Meets clinical response criteria at week 14 • Responder: Mayo score: 50% reduction / >= 3 improvement from baseline, but does not meet the criteria for remission; endoscopic Mayo: Does not meet the criteria for clinical response, but shows a reduction in Mayo ES • Partial Responder: Mayo score: reduction to 30%, endoscopic Mayo: no formal improvement from Mayo ES but slight improvement in general physician assessment. • Non Responder: Reduction of less than 30% and no improvement in overall assessment at endoscopy

—

Secondary

Measure	Time frame
• diepe klinische remissie (Mayo-score 0-1 met SF	—

Countries

Netherlands

Outcome results