Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT03501758
Eligibility Criteria:
Inclusion Criteria:
* A confirmed diagnosis of ulcerative colitis
* Six-point Mayo score ≤ 1
* Two consecutive faecal calprotectin tests \<200 mg/kilogram
* Male or non-pregnant, non-nursing female
-\>18 years of age at inclusion
* Patients treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment in sustained clinical remission during the last 3 months
* Subject capable of understanding and signing an informed consent form
Exclusion Criteria:
* Discontinuation of systemic 5-acetylsalicylic acid (ASA) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
* Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission.
* Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
* Change in the anti-TNF treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
* Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
* Previous failed attempts of anti-TNF discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy
* Detection of anti-TNF antibodies in moderate-high titers prior to randomization
* Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
* Pregnancy
* Breastfeeding
* Participation in any other investigational medicinal Product (IMP) studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03501758
Study Brief:
Protocol Section:
NCT03501758