Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-07 @ 11:01 PM
Study NCT ID:
NCT00645905
Status:
COMPLETED
Last Update Posted:
2008-03-28
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-26', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index', 'timeFrame': 'Week 12-Week 24'}, {'measure': 'Adverse Events', 'timeFrame': 'Throughout Study Participation'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index', 'timeFrame': 'Week 12, Week 24 through 360 days after last dose'}, {'measure': "Physician's Global Assessment", 'timeFrame': 'Week 12, Week 24 through 360 days after last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate to severe chronic plaque psoriasis\n* Active psoriasis, despite topical therapies\n\nExclusion Criteria:\n\n* Other active skin diseases or skin infections\n* Prior exposure to any anti-TNF therapy\n* Subject has other active skin diseases\n* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)\n* Poorly controlled medical conditions\n* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease\n* History of cancer or lymphoproliferative disease\n* History of active TB or listeriosis, or persistent chronic or active infections\n* Known to have immune deficiency or is immunocompromised\n* Clinically significant abnormal laboratory test results\n* Erythrodermic psoriasis or generalized pustular psoriasis'}, 'identificationModule': {'nctId': 'NCT00645905', 'briefTitle': 'Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'M02-538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: placebo for adalimumab']}], 'interventions': [{'name': 'adalimumab', 'type': 'DRUG', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose', 'armGroupLabels': ['A']}, {'name': 'placebo for adalimumab', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose', 'armGroupLabels': ['B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Beverly Paperiello / Director, Clinical Program Management', 'oldOrganization': 'Abbott'}}}}