Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial
Key facts
- Where
- Tromsoe, NorvégiaSee the site
- Phase
- 2. fázis
Where in Norvégia
- Universitetssykehuset Nord-Norge HFTromsoe, NorvégiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitetssykehuset Nord-Norge HF
- Trial code
- EU 2024-519891-17-00
- Record updated
- 2026. október 23.
- Original description
Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial.Read full original descriptionShow less
Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial.
This is a proof-of-concept study to evaluate selective top-down treatment algorithm for a subgroup of patients with ulcerative colitis identified as probable severe 1-year outcome by a bio-signature. Positive bio-signature defined as mucosal TNF transcript ≥ 14100 copies/ug RNA and RHI ≥ 9.
Hypothesis: For the most severe cases early biologic therapy (top-down) has a higher chance of achieving deep remission at one year after debut than the regular step-up regimen.
Inclusion: Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent; Participants who are newly diagnosed with ulcerative colitis (colonscopy and biopsy that confirm the diagnosis); Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; Women with childbearing potential must use highly efficient contraception during and 6 months after the last infliximab administration.
Exclusion: Concurrent treatment with other biologic agents, including anakinra and abatacept; Participants who are required to recive live vaccines during the study period; Any condition that by standard clinical practice preclude the use of biologic therapy as per local guidelines, including but not exclusive: a. Malignancies declared healed less than 5 years earlier b. Evidence of ongoing or latent tuberculosis according to IGRA test, TB-SPOT or similar local testing practice c. Evidence of ongoing or latent untreated HBV or HCV infection; Severe infections such as sepsis, abscesses or opportunistic infections; Moderate to severe heart failure (NYHA class III/IV); Alternative diagnosis like C difficile or enteropathogenic infection likely to affect the clinical presentation; Patients with multiple sclerosis or similar neurological/demyelinating conditions; Fulminant colitis; Pregnant or planned pregnancy during the study period; Participation in other clinical trials or research studies that may interfere with the current study.