ADALIMUMAB for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.\n- Participants who are newly diagnosed with ulcerative colitis (colonscopy and biopsy that confirm the diagnosis)\n- 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\n- Women with childbearing potential must use highly efficient contraception during and 5 months after the last adalimumab administration"}

Exclusion criteria

• {"criterion_text":"- Any condition that by standard clinical practice preclude the use of biologic therapy as per local guidelines, including but not exclusive: a.\tMalignancies declared healed less than 5 years earlier b.\tEvidence of ongoing or latent tuberculosis according to IGRA test, TB-SPOT or similar local testing practice c.\tEvidence of ongoing or latent untreated HBV or HCV infection\n- Fulminant colitis\n- Severe infections such as sepsis, abscesses or opportunistic infections\n- Moderate to severe heart failure (NYHA class III/IV)\n- Alternative diagnosis like C difficile or enteropathogenic infection likely to affect the clinical presentation\n- Pregnant or planned pregnancy during the study period.\n- Participation in other clinical trials or research studies that may interfere with the current study.\n- Participants who are required to recive live vaccines during the study period"}

Primary endpoints

• {"endpoint_text":"- Primary outcome Main Study: Percentage of patients in deep remission 1 year after debut (defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3.","definition_or_measurement_approach":"Defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3 (percentage of patients in deep remission 1 year after debut)."}
• {"endpoint_text":"- Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease","definition_or_measurement_approach":"As stated: percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcomes: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review.","definition_or_measurement_approach":"Evaluate change in patient-reported scores (IBD-QoL, SCCAI) from baseline; medical expenditures assessed by retrospective questionnaire and medical records review."}
• {"endpoint_text":"- Secondary endpoint: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review after 3 years.","definition_or_measurement_approach":"Evaluate change in patient-reported scores (IBD-QoL, SCCAI) from baseline; medical expenditures assessed by retrospective questionnaire and medical records review after 3 years."}
• {"endpoint_text":"- Exploratory outcomes: Improvement of the proposed biosignature based on data from all 200 included subjects.","definition_or_measurement_approach":"Improvement of the proposed biosignature measured using data collected from all 200 included subjects."}

Norway

Earliest CTIS Part Ii Submission Date

26-05-2025

Latest Decision Or Authorization Date

19-06-2025

Processing Time Days

24

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Universitetssykehuset Nord-Norge HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway