Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT00338650
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2006-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)
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': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs, laboratory data, physical examinations and vital signs'}], 'secondaryOutcomes': [{'measure': 'Efficacy variables will be assessed from Outcomes Questionnaires'}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '20955442', 'type': 'DERIVED', 'citation': "Lichtiger S, Binion DG, Wolf DC, Present DH, Bensimon AG, Wu E, Yu AP, Cardoso AT, Chao J, Mulani PM, Lomax KG, Kent JD. The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy. Aliment Pharmacol Ther. 2010 Nov;32(10):1228-39. doi: 10.1111/j.1365-2036.2010.04466.x. Epub 2010 Sep 28."}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient diagnosed with moderate to severe Crohn's Disease.\n* Failed prior infliximab therapy.\n* Patient is judged to be in generally good health as determined by the principal investigator.\n\nExclusion Criteria:\n\n* Previous treatment with adalimumab.\n* Patient considered by the investigator, for any reason, to be an unsuitable candidate"}, 'identificationModule': {'nctId': 'NCT00338650', 'briefTitle': "Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate 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