Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-04-05 @ 9:38 AM
Study NCT ID:
NCT00207766
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-26', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the number of draining fistulas'}], 'secondaryOutcomes': [{'measure': 'Complete fistula response (no draining fistula).'}]}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'infusions'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '15476155', 'type': 'RESULT', 'citation': "Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8."}, {'pmid': '14985485', 'type': 'RESULT', 'citation': "Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815."}]}, 'descriptionModule': {'briefSummary': "A study of infliximab in patients with Fistulizing Crohn's Disease", 'detailedDescription': "This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas.\n\nSubjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Single or multiple draining fistulas\n* Crohn's disease of at least 3 months' duration,\n\nExclusion Criteria:\n\n* Crohn's disease complications for which surgery might be indicated\n* Positive stool culture"}, 'identificationModule': {'nctId': 'NCT00207766', 'briefTitle': "A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': "ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease", 'orgStudyIdInfo': {'id': 'CR005413'}}, 'armsInterventionsModule': {'interventions': [{'name': 'infliximab or placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Centocor, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centocor, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}}}}