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

Helse Møre og Romsdal HF174 enrolled

Overview

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

The BIOSTOP study is a prospective, open randomized, multicenter, parallel-group study to compare clinical outcome of discontinuing (interventional group) compared to continuing (control group) biologic treatment with anti-TNF in ulcerative colitis patients in clinical remission. Adult male and female patients with an established diagnosis of ulcerative colitis treated for minimum one year with anti-TNF maintenance therapy and being in clinical remission during the last 3 months are potential study patients. Eligible patients who have given their informed written consent will be randomized 1:1 to either discontinue anti-TNF treatment or to continue anti-TNF treatment for another two years. Patients in the control group who are still in clinical and endoscopic remission after two years on continued anti-TNF treatment, will then be switched to discontinue anti-TNF treatment. End of study/follow-up is after 4 years. In order to identify the primary endpoint (occurrence of disease relapse), each study center will have a phone number for patients to call in case of symptoms suspect of increased disease activity. If a patient is experiencing a potential disease flare (6-point Mayo score \> 1) and/or 2 consecutive calprotectin tests are positive (\> 200 mg/kg), an unscheduled visit including recto sigmoidoscopy will be performed without delay to document disease status. 150 participants enrolled, September 2020 Covid 19 - randomization period extended until 31.12.2020

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Colitis,Ulcerative

Interventions

Discontinuation of anti-TNF treatmentOTHER

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

Continuation of anti-TNF treatmentOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Helse Møre og Romsdal, Ålesund Sjukehus

Ålesund, Norway

Haraldsplass Diakonale sykehus

Bergen, Norway

Outcomes

Primary Outcomes

Proportion of patients in sustained clinical remission

Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment

Time frame: 2 years

Secondary Outcomes

Proportion of patients in sustained clinical remission

Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 4 years of randomized treatment

Time frame: 4 years

Time from randomization to relapse

Relapse time

Time frame: 2 years

Time from randomization to relapse

Relapse time

Time frame: 4 years

Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy

Remission, but no need to restart anti-tnf therapy

Time frame: 2 years

Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy

Remission, but no need to restart anti-tnf therapy

Time frame: 4 years

Proportion of relapse patients achieving remission after anti-TNF restart

Remission after relapse

Time frame: 2 years

Proportion of relapse patients achieving remission after anti-TNF restart

Data from ClinicalTrials.gov

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