Ulcerative colitis
Conditions
Brief summary
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., Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease
Detailed description
Secondary outcomes: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review., 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., Exploratory outcomes: Improvement of the proposed biosignature based on data from all 200 included subjects.
Interventions
Sponsors
Universitetssykehuset Nord-Norge HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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., Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review., 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., Exploratory outcomes: Improvement of the proposed biosignature based on data from all 200 included subjects. | — |
Countries
Norway
Outcome results
None listed