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

Helse Møre og Romsdal HF

Status

Completed

Conditions

Colitis,Ulcerative

Treatments

Other: Discontinuation of anti-TNF treatment

Other: Continuation of anti-TNF treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03011268

HMR2016-0.6

2016-001409-18 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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