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Colitis,UlcerativeBIOSTOPNCT03011268

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

A study testing Discontinuation of anti-TNF treatment and Continuation of anti-TNF treatment in people with Colitis,Ulcerative, run by Helse Møre og Romsdal HF at 19 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis,Ulcerative
What is being tested?
Discontinuation of anti-TNF treatment and Continuation of anti-TNF treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
19 sitesNorway
Study dates
9 Jun 2017to 20 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Norway19 sites

  • Helse Møre og Romsdal, Ålesund Sjukehus

    Ålesund

  • Haraldsplass Diakonale sykehus

    Bergen, 5009

  • Haukeland Universitetssykehus Helse Bergen HF

    Bergen

  • Helse Førde, Førde Sentralsjukehus

    Førde

  • Sykehuset Østfold HF Kalnes

    Fredrikstad

  • Sykehuset Innlandet, Hamar Sykehus

    Hamar

  • Universitetssykehuset i Nord-Norge, Harstad

    Harstad

  • Sørlandet Sykehus HF, Kristiansand

    Kristiansand

  • Helse Møre og Romsdal, Kristiansund Sjukehus

    Kristiansund

  • Helse Nord Trøndelag, Levanger Sykehus

    Levanger

  • Akershus Universitetssykehus, Lørenskog

    Lørenskog, 1478

  • Oslo Universitetssykehus, Rikshospitalet

    Oslo

  • Oslo Universitetssykehus, Ullevål

    Oslo

  • Vestre Viken HF, Bærum Sykehus

    Sandvika

  • Sykehuset Telemark, Skien

    Skien

  • Stavanger Universitetssykehus

    Stavanger

  • Sykehuset Vestfold, Tønsberg

    Tønsberg

  • Helse Møre og Romsdal, Volda Sjukehus

    Volda

  • Helse Bergen HF Voss Sjukehus

    Voss

Other trials in Norway

About this study

Official title: Continuing or Discontinuing Anti-tumor Necrosis Factor Treatment in Patients With Ulcerative Colitis in Clinical Remission: a Prospective Open Randomized Parallel-group Study

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

Read the 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

Being tested
Discontinuation of anti-TNF treatment, Continuation of anti-TNF treatment
Keywords
Tumor Necrosis Factor-alpha/antagonists & inhibitors, Infliximab, Adalimumab, Golimumab, Recurrence
Medical subject headings
Colitis, Ulcerative, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Discontinuation of anti-TNF treatmentOther

    Also called Remicade, Remsima, Inflectra, Humira, Simponi

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

  • Continuation of anti-TNF treatmentOther

    Also called Remicade, Remsima, Inflectra, Humira, Simponi

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

Study groups in NCT03011268
Study groupRoleWhat they receive
Anti TNF discontinuationExperimentalDiscontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
Receives: Other: Discontinuation of anti-TNF treatment
Anti TNF continuationActive comparatorContinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
Receives: Other: Continuation of anti-TNF treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (9)

  1. 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

    Measured: 4 years

  2. Time from randomization to relapse

    Relapse time

    Measured: 2 years

  3. Time from randomization to relapse

    Relapse time

    Measured: 4 years

  4. 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

    Measured: 2 years

  5. 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

    Measured: 4 years

  6. Proportion of relapse patients achieving remission after anti-TNF restart

    Remission after relapse

    Measured: 2 years

  7. Proportion of relapse patients achieving remission after anti-TNF restart

    Remission after relapse

    Measured: 4 years

  8. Adverse events and serious adverse events frequency and severity

    Adverse events

    Measured: 2 years

  9. Adverse events and serious adverse events frequency and severity

    Adverse events

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study start9 Jun 2017
  3. Primary completion20 Jan 2025
  4. Study completion20 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011268
Sponsor's protocol ID
HMR2016-0.6
Other IDs
2016-001409-18, 2016
Acronym
BIOSTOP
Status last verified
May 2025
First submitted
2 Jan 2017
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this time there is no such plan for IPD sharing. It might be an issue regarding material stored in the study Biobank - that will be elucidated at a later stage.

Publications

  • Berset IP, Lerang F, Moum B, Jahnsen J, Grimstad T, Kristensen V, Wiig H, Aabrekk T, Ness-Jenssen E, Eskeland S, Melsom E, Von Volkmann H, Huppertz-Hauss G, Torp R, Hovlid O, Buset M, Riise G, Horvei G, Finjord T, Jelsness-Jorgensen LP, Olsen IC, Jahnsen FL, Myklebust TA, Molsaeter K, Hoff DAL, Lundin KEA. Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial. J Crohns Colitis. 2026 Aug 5;20(8):jjag110. doi: 10.1093/ecco-jcc/jjag110.

    PubMed 42557857

Questions about this trial

What is this clinical trial studying?

A study testing Discontinuation of anti-TNF treatment and Continuation of anti-TNF treatment in people with Colitis,Ulcerative, run by Helse Møre og Romsdal HF at 19 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients in sustained clinical remission (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03011268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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