Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-29 @ 11:46 AM
Study NCT ID:
NCT01848561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2013-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['American Samoa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8250}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC', 'timeFrame': '10 years observational period'}], 'secondaryOutcomes': [{'measure': 'Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy', 'timeFrame': '10 years observational period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Registry', 'Adalimumab', 'Colitis', 'Gastroenteritis', 'Inflammatory Bowel Diseases', 'Gastrointestinal Diseases'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with moderately to severely active Ulcerative Colitis (UC) who have been prescribed HUMIRA according to the local label and adult patients being prescribed and treated with IMM (6-mercaptopurine or azathioprine) with no concurrent biologic use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:\n\n 1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR\n 2. Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy\n* For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy\n* Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol\n\nExclusion Criteria:\n\n* Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or\n* Patients who are being treated with any investigational agents and/or approved biologics other than Humira.'}, 'identificationModule': {'nctId': 'NCT01848561', 'acronym': 'LEGACY', 'briefTitle': 'A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)', 'orgStudyIdInfo': {'id': 'P11-282'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunomodulatory Therapy', 'description': 'Patients who are being prescribed and treated with Immunomodulatory Therapy'}, {'label': 'Adalimumab (Humira) Treatment', 'description': 'Patients who are prescribed and treated with Adalimumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Gastroenterology Associates P.C /ID# 102063', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - Main /ID# 131646', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Longwood Research /ID# 118662', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'East View Medical Research, LLC /ID# 116259', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Medical & Diagnostic Center, AL /ID# 102064', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute /ID# 127947', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719-1478', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duplicate_University of Arizona Cancer Center - North Campus /ID# 140387', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University Of Arizona /ID# 117836', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Gastroenterology /ID# 113898', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '92118-1408', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Res. 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