K51.9
Conditions
Interventions
Group 1: Only one study arm
No proper study intervention is planned.
Concomitant to the standard clinical appointments and routine blood tests at weeks 0, 6, 14, 26, 52, 78 and 104 post induction o
Sponsors
Universitätskliniikum Schleswig-Holstein, Campus Kiel Klinik für Innere Medizin I für die deutschen Partner der multizentrischen Studie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • deep clinical remission (Mayo Score 0-1 with SF =1 and RB = 0) • mucosal healing (Mayo ES = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1). • symptomatic remission assessed by patient-reported outcome PRO 2 (SF 0-1 and RB 0) • disease progression e.g. flares • complications until week 52 o hospitalizations due to UC o treatment intensification including introduction of toxic long-term therapies (i.e. systemic glucocorticoids) o new stenosis o new fistula o new development of PSC o infections o intestinal surgery | — |
Countries
Belgium, France, Germany, Netherlands, United Kingdom
Contacts
Public ContactSabrina Fritz
Universitätsklinikum Schleswig-Holstein, Campus Kiel Klinik für Innere Medizin I
Outcome results
None listed