Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 1:41 AM
Study NCT ID:
NCT00131066
Status:
COMPLETED
Last Update Posted:
2008-09-22
First Post:
2005-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Study of Psoriasis Patients
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': 'C544394', 'term': 'siplizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-18', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Previously enrolled on a MEDI-507 for psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.', 'detailedDescription': 'This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507. Patients must have had an ALC \\> 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure); or an absolute CD4 count of \\< 250 cells/uL. This study will also evaluate the development and durability of anti-MEDI-507 antibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient has previously completed participation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has previously completed participation (i.e., completed per protocol, including any long term follow-up; or discontinued from the study due to withdrawal of consent, loss to follow-up, or other reason) in a Medimmune, Inc. study of MEDI-507 in psoriasis in which they received MEDI-507 (or placebo for patients who participated in a blinded placebo-controlled study of MEDI-507, and for whom the treatment assignment in that study has not been unblinded at the time of entry into this study)\n* The patient had an absolute lymphocyte count (ALC) \\> 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure; or, for patients whose treatment assignments have not been unblinded at the time of entry into this study, drug exposure) at his/her final visit (excluding any long-term follow-up visits) in the most recent Medimmune, Inc. study in which the patient participated; or the patient had an absolute CD4 count of \\< 250 cells/uL at his/her final visit (including any protocol-specific long-term follow up) in the most recent Medimmune, Inc. study in which the patient participated.\n* Written informed consent obtained from the patient\n\nExclusion Criteria:\n\n* There are no exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00131066', 'briefTitle': 'Long-Term Follow-Up Study of Psoriasis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507', 'orgStudyIdInfo': {'id': 'MI-CP085'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Follow up from previous treatment with MEDI-507', 'type': 'OTHER', 'description': 'There will be no investigational drugs administered under this protocol.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Dermatology Research Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Cherry Creek Dermatology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Dermatology, Vein & Research Center, LLC', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '72205', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Future Care Studies', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University, Dermatology Clinical Trials Unit', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Kinetics', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '185', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitaur Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4020', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Centre Ville', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'B3H1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District Health Authority, QE II Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H3H1V4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'International Dermatology Research', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2K 4L5', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Innovaderm Research', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'F-44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Hotel Dieu/Clinque Dermatologique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': 'F-75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Saint-Louis Service de Dermatologie 1', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'F-33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Hospital Haut Leveque CHU Sud -Service de Dermatologie', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitataskilinkum der TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'D-40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitatsklinikum Hautklinik', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-79104', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'St. Urban, Dermatologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitatsklinikum Hautklinik', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '1105', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Barbara White, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Barbara White', 'oldOrganization': 'MedImmune Inc.'}}}}