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

Not Applicable

Active, not recruiting

• Conditions: Colitis,Ulcerative
• Interventions: Other: Continuation of anti-TNF treatment; Other: Discontinuation of anti-TNF treatment

• Registration Number: NCT03011268
• Lead Sponsor: Helse Møre og Romsdal HF

Brief 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

Detailed Description

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Start: 2017-06-09
• Primary Completion: 2023-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 174

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti TNF continuation	Continuation of anti-TNF treatment	Continuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
Anti TNF discontinuation	Discontinuation of anti-TNF treatment	Discontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)

Primary Outcome Measures

Name	Time	Method
Proportion of patients in sustained clinical remission	2 years	Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy	4 years	Remission, but no need to restart anti-tnf therapy
Proportion of relapse patients achieving remission after anti-TNF restart	4 years	Remission after relapse
Time from randomization to relapse	4 years	Relapse time
Proportion of patients in sustained clinical remission	4 years	Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 4 years of randomized treatment
Adverse events and serious adverse events frequency and severity	4 years	Adverse events

Trial Locations

Locations (19)

Helse Møre og Romsdal, Kristiansund Sjukehus; 🇳🇴 Kristiansund, Norway

Sykehuset Vestfold, Tønsberg; 🇳🇴 Tonsberg, Norway

Helse Møre og Romsdal, Ålesund Sjukehus; 🇳🇴 Alesund, Norway

Sykehuset Telemark, Skien; 🇳🇴 Skien, Norway

Haukeland Universitetssykehus Helse Bergen HF; 🇳🇴 Bergen, Norway

Helse Førde, Førde Sentralsjukehus; 🇳🇴 Forde, Norway

Sørlandet Sykehus HF, Kristiansand; 🇳🇴 Kristiansand, Norway

Helse Nord Trøndelag, Levanger Sykehus; 🇳🇴 Levanger, Norway

Oslo Universitetssykehus, Rikshospitalet; 🇳🇴 Oslo, Norway

Sykehuset Østfold HF Kalnes; 🇳🇴 Fredrikstad, Norway

Universitetssykehuset i Nord-Norge, Harstad; 🇳🇴 Harstad, Norway

Helse Møre og Romsdal, Volda Sjukehus; 🇳🇴 Volda, Norway

Helse Bergen HF Voss Sjukehus; 🇳🇴 Voss, Norway

Haraldsplass Diakonale sykehus; 🇳🇴 Bergen, Norway

Oslo Universitetssykehus, Ullevål; 🇳🇴 Oslo, Norway

Stavanger Universitetssykehus; 🇳🇴 Stavanger, Norway

Sykehuset Innlandet, Hamar Sykehus; 🇳🇴 Hamar, Norway

Vestre Viken HF, Bærum Sykehus; 🇳🇴 Sandvika, Norway

Akershus Universitetssykehus, Lørenskog; 🇳🇴 Lørenskog, Norway