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

NCT03011268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-05-31

No results posted yet for this study

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

Conditions

  • Colitis,Ulcerative

Interventions

OTHER

Discontinuation of anti-TNF treatment

Discontinuation of treatment with Infliximab, Adalimumab, and Golimumab in order to record time to relapse occurrences

OTHER

Continuation of anti-TNF treatment

Continuation of treatment with Infliximab, Adalimumab, and Golimumab for 2 years after randomization, then discontinue

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Helse Møre og Romsdal HF

    lead OTHER_GOV

Principal Investigators

  • Dag Arne L Hoff, md, phd · Helse Møre og Romsdal Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2025-01-20
Completion
2025-01-20

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011268 on ClinicalTrials.gov