Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-31 @ 11:27 AM
Study NCT ID:
NCT03261206
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD-related complications at 2 years', 'timeFrame': '24 months', 'description': 'CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication'}], 'secondaryOutcomes': [{'measure': 'CD-related complications at 1 year', 'timeFrame': '12 months', 'description': 'CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication'}, {'measure': 'CD-related or CD-treatment related surgeries at 1 year', 'timeFrame': '12 months'}, {'measure': 'CD-related or CD-treatment related surgeries at 2 years', 'timeFrame': '24 months'}, {'measure': 'CD-related or CD-treatment related hospitalizations at 1 year', 'timeFrame': '12 months'}, {'measure': 'CD-related or CD-treatment related hospitalizations at 2 years', 'timeFrame': '24 months'}, {'measure': 'Other CD-related or CD-treatment related complications at 1 year', 'timeFrame': '12 months', 'description': 'Other complication excludes surgeries or hospitalizations'}, {'measure': 'Other CD-related or CD-treatment related complications at 2 years', 'timeFrame': '24 months', 'description': 'Other complication excludes surgeries or hospitalizations'}, {'measure': 'Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year', 'timeFrame': '12 months'}, {'measure': 'Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years', 'timeFrame': '24 months'}, {'measure': 'Time to first CD-related complication', 'timeFrame': 'up to 24 months', 'description': 'CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication'}, {'measure': 'Change in disease activity at 6 months', 'timeFrame': '6 months', 'description': 'Disease activity assessed by HBI score'}, {'measure': 'Change in disease activity at 12 months', 'timeFrame': '12 months', 'description': 'Disease activity assessed by HBI score'}, {'measure': 'Change in disease activity at 24 months', 'timeFrame': '24 months', 'description': 'Disease activity assessed by HBI score'}, {'measure': 'Change in self-assessed quality of life at 6 months', 'timeFrame': 'Base line and 6 months', 'description': "Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item"}, {'measure': 'Change in self-assessed quality of life at 1 year', 'timeFrame': 'Base line and 12 months', 'description': "Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item"}, {'measure': 'Change in self-assessed quality of life at 2 years', 'timeFrame': 'Base line and 24 months', 'description': "Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item"}, {'measure': 'Change in C-reactive protein concentration at 6 months', 'timeFrame': 'Base line and 6 months'}, {'measure': 'Change in C-reactive protein concentration at 1 year', 'timeFrame': 'Base line and 12 months'}, {'measure': 'Change in C-reactive protein concentration at 2 years', 'timeFrame': 'Base line and 24 months'}, {'measure': 'Change in fecal calprotectin concentration at 1 year', 'timeFrame': 'Base line and 12 months'}, {'measure': 'Change in fecal calprotectin concentration at 2 years', 'timeFrame': 'Base line and 24 months'}, {'measure': 'Change in CD-related drug treatment costs at 2 years', 'timeFrame': '12 months prior to enrollment and 24 months after enrollment', 'description': 'Estimated drug treatment costs before and after enrollment'}, {'measure': 'Change in CD-related and total healthcare costs at 2 years', 'timeFrame': '12 months prior to enrollment and 24 months after enrollment', 'description': 'Estimated costs before and after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Remission']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.", 'detailedDescription': "Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.\n\nIn this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of CD at least 3 months prior to enrollment\n* Taking any brand or dosage of an oral aminosalicylate for at least 6 months\n* Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)\n* CD currently in clinical remission\n* Able to participate fully in all aspects of the clinical trial\n* Written informed consent obtained and documented\n\nExclusion Criteria:\n\n* A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis\n* A diagnosis of short-bowel syndrome\n* Active perianal disease\n* Active fistulizing disease\n* A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery\n* Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment\n* Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment\n* Unwillingness to stop taking aminosalicylates for the duration of the trial\n* Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment\n* Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study\n* History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures\n* Currently participating in another interventional trial, or previous participation within the last 3 months"}, 'identificationModule': {'nctId': 'NCT03261206', 'acronym': 'STATIC', 'briefTitle': "Stopping Aminosalicylate Therapy in Inactive Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Alimentiv Inc.'}, 'officialTitle': "Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial", 'orgStudyIdInfo': {'id': 'RP1610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '5-ASA Continuation', 'description': 'Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study'}, {'type': 'EXPERIMENTAL', 'label': '5-ASA Withdrawal', 'description': 'Half of the subjects will discontinue their aminosalicylate therapy', 'interventionNames': ['Other: 5-ASA Withdrawal']}], 'interventions': [{'name': '5-ASA Withdrawal', 'type': 'OTHER', 'description': 'Withdrawal of 5-ASA therapy', 'armGroupLabels': ['5-ASA Withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L8S 4K1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 6K3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Dr. Jesse Siffledeen Professional Medical Corporation', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': '(G.I.R.I.) GI Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8T 5G4', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Discovery Clinical Services Ltd.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba - Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre - University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'P1B2H3', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Scott Shulman Medical Professional Corporation', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'L1H 7K4', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Taunton Surgical Center', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 1E6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. O. 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