Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?

Prior treatment

• Discontinuation of systemic 5-Aminosalicylic acid (ASA) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
• Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
• 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

Other illness

• Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission)
• 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
• Psychiatric or mental disorders

Other

• Alcohol abuse or other substance abuse
• language barriers or other factors which makes adherence to the study protocol impossible
• Participation in any other studies
• pregnancy
• breastfeeding

• confirmed diagnosis of ulcerative colitis
• treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment
• in sustained clinical remission during the last 3 months
• capable of understanding and signing an informed consent form