Continuing or Discontinuing Anti-tumor Necrosis Factor Treatment in Patients With Ulcerative Colitis in Clinical Remission: a Prospective Open Randomized Parallel-group Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Møre og Romsdal HF
- Enrollment
- 174
- Locations
- 24
- Primary Endpoint
- Proportion of patients in sustained clinical remission
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of patients in sustained clinical remission
Time Frame: 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 Outcomes
- Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy(4 years)
- Proportion of relapse patients achieving remission after anti-TNF restart(4 years)
- Time from randomization to relapse(4 years)
- Proportion of patients in sustained clinical remission(4 years)
- Adverse events and serious adverse events frequency and severity(4 years)