Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT00096603
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2004-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
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': 'C472181', 'term': 'efalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2004-11-12', 'studyFirstSubmitQcDate': '2004-11-12', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Moderate to severe plaque psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is an open label, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in Study ACD2600g.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Previous participation in Study ACD2600g\n* For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab"}, 'identificationModule': {'nctId': 'NCT00096603', 'briefTitle': 'A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g', 'orgStudyIdInfo': {'id': 'ACD2601g'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Raptiva (efalizumab)', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}