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

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 200
• Participant gender: Both

Summary

The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helse Møre og Romsdal HF
• Collaborators: Oslo University Hospital; University of Oslo
• Treatments: Adalimumab; Infliximab
• Last Updated: 2017-01-03

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

• Participation in any other studies

• pregnancy

• breastfeeding