Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-04-12 @ 11:07 PM
Study NCT ID:
NCT01053559
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2010-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-05-26', 'releaseDate': '2016-04-20'}], 'estimatedResultsFirstSubmitDate': '2016-04-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal Healing', 'timeFrame': '180 Days'}], 'secondaryOutcomes': [{'measure': 'C-Reactive Protein (CRP) Level', 'timeFrame': '180 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's", 'Inflammatory Bowel Disease'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.shafran.net', 'label': 'Practice Website'}]}, 'descriptionModule': {'briefSummary': "Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease\n* Moderately to severely active disease (CDAI score \\>220 and \\< 450)\n* Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants\n\nExclusion Criteria:\n\n* Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure \\[CHF\\], cytopenia)\n* Small bowel obstruction, stricture, or any contraindication for capsule endoscopy\n* Previous treatment with certolizumab pegol\n* Are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT01053559', 'briefTitle': "Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy", 'organization': {'class': 'OTHER', 'fullName': 'Shafran Gastroenterology Center'}, 'officialTitle': "Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy", 'orgStudyIdInfo': {'id': 'Exempt IND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'certolizumab pegol', 'description': 'Subjects will receive FDA approved Cimzia injections as indicated on the product label. Subjects will undergo 3 wireless capsule endoscopies, one at screening,Day 84 and Day 168 as well as monthly bloodwork.', 'interventionNames': ['Drug: certolizumab pegol']}], 'interventions': [{'name': 'certolizumab pegol', 'type': 'DRUG', 'otherNames': ['Cimzia'], 'description': '400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter', 'armGroupLabels': ['certolizumab pegol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Shafran Gastroenterology Center', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}], 'overallOfficials': [{'name': 'Ira Shafran, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shafran Gastroenterology Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shafran Gastroenterology Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ira Shafran M.D.', 'investigatorAffiliation': 'Shafran Gastroenterology Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-04-20', 'type': 'RELEASE'}, {'date': '2016-05-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ira Shafran M.D., Principal Investigator, Shafran Gastroenterology Center'}}}}