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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03011268

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Helse Møre og Romsdal HF

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Dag Arne L Hoff, md, phd
Principal Investigator Affiliation Helse Møre og Romsdal Hospital Trust

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOther
Overall Status Recruiting
Countries Norway

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis,Ulcerative
Additional Details

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. 103 participants enrolled per January 4th, 2019

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Helse Møre og Romsdal, Ålesund Sjukehus, Alesund, Norway

Status

Recruiting

Address

Helse Møre og Romsdal, Ålesund Sjukehus

Alesund, ,

Site Contact

+ 4770105000

Sørlandet Sykehus HF, Arendal, Arendal, Norway

Status

Not yet recruiting

Address

Sørlandet Sykehus HF, Arendal

Arendal, ,

Site Contact

+ 4770105000

Bergen, Norway

Status

Recruiting

Address

Haukeland Universitetssykehus Helse Bergen HF

Bergen, ,

Site Contact

+ 4770105000

Nordlandssykehuset HF, Bodø, Bodo, Norway

Status

Not yet recruiting

Address

Nordlandssykehuset HF, Bodø

Bodo, ,

Site Contact

+ 4770105000

Vestre Viken HF, Drammen Sykehus, Drammen, Norway

Status

Not yet recruiting

Address

Vestre Viken HF, Drammen Sykehus

Drammen, ,

Site Contact

+ 4770105000

Helse Førde, Førde Sentralsjukehus, Forde, Norway

Status

Recruiting

Address

Helse Førde, Førde Sentralsjukehus

Forde, ,

Site Contact

+ 4770105000

Sykehuset Østfold HF Kalnes, Fredrikstad, Norway

Status

Recruiting

Address

Sykehuset Østfold HF Kalnes

Fredrikstad, ,

Site Contact

+ 4770105000

Sykehuset Innlandet, Gjøvik Sykehus, Gjovik, Norway

Status

Not yet recruiting

Address

Sykehuset Innlandet, Gjøvik Sykehus

Gjovik, ,

Site Contact

+ 4770105000

Sykehuset Innlandet, Hamar Sykehus, Hamar, Norway

Status

Recruiting

Address

Sykehuset Innlandet, Hamar Sykehus

Hamar, ,

Site Contact

+ 4770105000

Harstad, Norway

Status

Recruiting

Address

Universitetssykehuset i Nord-Norge, Harstad

Harstad, ,

Site Contact

+ 4770105000

Sørlandet Sykehus HF, Kristiansand, Kristiansand, Norway

Status

Recruiting

Address

Sørlandet Sykehus HF, Kristiansand

Kristiansand, ,

Site Contact

+ 4770105000

Kristiansund, Norway

Status

Recruiting

Address

Helse Møre og Romsdal, Kristiansund Sjukehus

Kristiansund, ,

Site Contact

+ 4770105000

Helse Nord Trøndelag, Levanger Sykehus, Levanger, Norway

Status

Recruiting

Address

Helse Nord Trøndelag, Levanger Sykehus

Levanger, ,

Site Contact

+ 4770105000

Sykehuset Innlandet, Lillehammer Sykehus, Lillehammer, Norway

Status

Not yet recruiting

Address

Sykehuset Innlandet, Lillehammer Sykehus

Lillehammer, ,

Site Contact

+ 4770105000

Akershus Universitetssykehus, Lørenskog, Lørenskog, Norway

Status

Recruiting

Address

Akershus Universitetssykehus, Lørenskog

Lørenskog, , 1478

Site Contact

+ 4770105000

Helse Møre og Romsdal, Molde Sjukehus, Molde, Norway

Status

Not yet recruiting

Address

Helse Møre og Romsdal, Molde Sjukehus

Molde, ,

Site Contact

+ 4770105000

Helse Nord Trøndelag, Namsos Sykehus, Namsos, Norway

Status

Not yet recruiting

Address

Helse Nord Trøndelag, Namsos Sykehus

Namsos, ,

Site Contact

+ 4770105000

Lovisenberg Diakonale sykehus, Oslo, Norway

Status

Not yet recruiting

Address

Lovisenberg Diakonale sykehus

Oslo, ,

Site Contact

+ 4770105000

Oslo Universitetssykehus, Rikshospitalet, Oslo, Norway

Status

Recruiting

Address

Oslo Universitetssykehus, Rikshospitalet

Oslo, ,

Site Contact

+ 4770105000

Oslo Universitetssykehus, Ullevål, Oslo, Norway

Status

Recruiting

Address

Oslo Universitetssykehus, Ullevål

Oslo, ,

Site Contact

+ 4770105000

Vestre Viken HF, Bærum Sykehus, Sandvika, Norway

Status

Recruiting

Address

Vestre Viken HF, Bærum Sykehus

Sandvika, ,

Site Contact

+ 4770105000

Sykehuset Telemark, Skien, Skien, Norway

Status

Recruiting

Address

Sykehuset Telemark, Skien

Skien, ,

Site Contact

+ 4770105000

Stavanger Universitetssykehus, Stavanger, Norway

Status

Recruiting

Address

Stavanger Universitetssykehus

Stavanger, ,

Site Contact

+ 4770105000

Sykehuset Vestfold, Tønsberg, Tonsberg, Norway

Status

Recruiting

Address

Sykehuset Vestfold, Tønsberg

Tonsberg, ,

Site Contact

+ 4770105000

Tromso, Norway

Status

Not yet recruiting

Address

Universitetssykehuset i Nord-Norge, Tromsø

Tromso, ,

Site Contact

+ 4770105000

St. Olavs Hospital, Trondheim, Norway

Status

Not yet recruiting

Address

St. Olavs Hospital

Trondheim, ,

Site Contact

+ 4770105000

Helse Møre og Romsdal, Volda Sjukehus, Volda, Norway

Status

Recruiting

Address

Helse Møre og Romsdal, Volda Sjukehus

Volda, ,

Site Contact

+ 4770105000

Helse Bergen HF Voss Sjukehus, Voss, Norway

Status

Recruiting

Address

Helse Bergen HF Voss Sjukehus

Voss, ,

Site Contact

+ 4770105000

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