Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT03011268
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'C000591237', 'term': 'CT-P13'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'C529000', 'term': 'golimumab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients in sustained clinical remission', 'timeFrame': '2 years', 'description': 'Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients in sustained clinical remission', 'timeFrame': '4 years', 'description': 'Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 4 years of randomized treatment'}, {'measure': 'Time from randomization to relapse', 'timeFrame': '2 years', 'description': 'Relapse time'}, {'measure': 'Time from randomization to relapse', 'timeFrame': '4 years', 'description': 'Relapse time'}, {'measure': 'Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy', 'timeFrame': '2 years', 'description': 'Remission, but no need to restart anti-tnf therapy'}, {'measure': 'Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy', 'timeFrame': '4 years', 'description': 'Remission, but no need to restart anti-tnf therapy'}, {'measure': 'Proportion of relapse patients achieving remission after anti-TNF restart', 'timeFrame': '2 years', 'description': 'Remission after relapse'}, {'measure': 'Proportion of relapse patients achieving remission after anti-TNF restart', 'timeFrame': '4 years', 'description': 'Remission after relapse'}, {'measure': 'Adverse events and serious adverse events frequency and severity', 'timeFrame': '2 years', 'description': 'Adverse events'}, {'measure': 'Adverse events and serious adverse events frequency and severity', 'timeFrame': '4 years', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor Necrosis Factor-alpha/antagonists & inhibitors', 'Infliximab', 'Adalimumab', 'Golimumab', 'Recurrence'], 'conditions': ['Colitis,Ulcerative']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nAdult 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.\n\nPatients 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.\n\nEnd 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.\n\n150 participants enrolled, September 2020 Covid 19 - randomization period extended until 31.12.2020'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* confirmed diagnosis of ulcerative colitis\n* treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment\n* in sustained clinical remission during the last 3 months\n* capable of understanding and signing an informed consent form\n\nExclusion Criteria:\n\n* 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\n* Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission)\n* Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy\n* 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\n* Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF\n* Previous failed attempts of anti-TNF discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy\n* Detection of anti-TNF antibodies in moderate-high titers prior to randomization\n* Psychiatric or mental disorders\n* Alcohol abuse or other substance abuse\n* language barriers or other factors which makes adherence to the study protocol impossible\n* Participation in any other studies\n* pregnancy\n* breastfeeding"}, 'identificationModule': {'nctId': 'NCT03011268', 'acronym': 'BIOSTOP', 'briefTitle': 'Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Møre og Romsdal HF'}, 'officialTitle': 'Continuing or Discontinuing Anti-tumor Necrosis Factor Treatment in Patients With Ulcerative Colitis in Clinical Remission: a Prospective Open Randomized Parallel-group Study', 'orgStudyIdInfo': {'id': 'HMR2016-0.6'}, 'secondaryIdInfos': [{'id': '2016-001409-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti TNF discontinuation', 'description': 'Discontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)', 'interventionNames': ['Other: Discontinuation of anti-TNF treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anti TNF continuation', 'description': 'Continuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)', 'interventionNames': ['Other: Continuation of anti-TNF treatment']}], 'interventions': [{'name': 'Discontinuation of anti-TNF treatment', 'type': 'OTHER', 'otherNames': ['Remicade, Remsima, Inflectra, Humira, Simponi'], 'description': 'Discontinuation of treatment with Infliximab, Adalimumab, and Golimumab in order to record time to relapse occurrences', 'armGroupLabels': ['Anti TNF discontinuation']}, {'name': 'Continuation of anti-TNF treatment', 'type': 'OTHER', 'otherNames': ['Remicade, Remsima, Inflectra, Humira, Simponi'], 'description': 'Continuation of treatment with Infliximab, Adalimumab, and Golimumab for 2 years after randomization, then discontinue', 'armGroupLabels': ['Anti TNF continuation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Helse Møre og Romsdal, Ålesund Sjukehus', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'zip': '5009', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haraldsplass Diakonale sykehus', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland Universitetssykehus Helse Bergen HF', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Fredrikstad', 'country': 'Norway', 'facility': 'Sykehuset Østfold HF Kalnes', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Førde', 'country': 'Norway', 'facility': 'Helse Førde, Førde Sentralsjukehus', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}, {'city': 'Hamar', 'country': 'Norway', 'facility': 'Sykehuset Innlandet, Hamar Sykehus', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'city': 'Harstad', 'country': 'Norway', 'facility': 'Universitetssykehuset i Nord-Norge, Harstad', 'geoPoint': {'lat': 68.79833, 'lon': 16.54165}}, {'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sørlandet Sykehus HF, Kristiansand', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'city': 'Kristiansund', 'country': 'Norway', 'facility': 'Helse Møre og Romsdal, Kristiansund Sjukehus', 'geoPoint': {'lat': 63.11045, 'lon': 7.72795}}, {'city': 'Levanger', 'country': 'Norway', 'facility': 'Helse Nord Trøndelag, Levanger Sykehus', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}, {'zip': '1478', 'city': 'Lørenskog', 'country': 'Norway', 'facility': 'Akershus Universitetssykehus, Lørenskog'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Sandvika', 'country': 'Norway', 'facility': 'Vestre Viken HF, Bærum Sykehus', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'city': 'Skien', 'country': 'Norway', 'facility': 'Sykehuset Telemark, Skien', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}, {'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger Universitetssykehus', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Tønsberg', 'country': 'Norway', 'facility': 'Sykehuset Vestfold, Tønsberg', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'city': 'Volda', 'country': 'Norway', 'facility': 'Helse Møre og Romsdal, Volda Sjukehus', 'geoPoint': {'lat': 62.146, 'lon': 6.07108}}, {'city': 'Voss', 'country': 'Norway', 'facility': 'Helse Bergen HF Voss Sjukehus', 'geoPoint': {'lat': 60.62869, 'lon': 6.41474}}], 'overallOfficials': [{'name': 'Dag Arne L Hoff, md, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helse Møre og Romsdal Hospital Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}