Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-05 @ 9:21 PM
Study NCT ID:
NCT00659412
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077944', 'term': 'Alefacept'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D018968', 'term': 'CD58 Antigens'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'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'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011993', 'term': 'Recombinant Fusion Proteins'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70', 'timeFrame': '12 Weeks and at any time'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25', 'timeFrame': 'Each scheduled efficacy visit'}, {'measure': "Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear", 'timeFrame': 'Each scheduled efficacy visit'}, {'measure': 'Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)', 'timeFrame': 'Baseline, 24 Weeks and 48 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriatic arthritis', 'psoriasis', 'Alefacept'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '16646026', 'type': 'BACKGROUND', 'citation': 'Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. doi: 10.1002/art.21870.'}, {'pmid': '19028407', 'type': 'BACKGROUND', 'citation': 'Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.', 'detailedDescription': 'Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psoriatic arthritis\n* MTX treatment for 3 months prior to enrollment with continuing disease\n* Normal T-cell count\n\nExclusion Criteria:\n\n* Other types of psoriasis\n* History of malignancy or lymphoproliferative disorder\n* Serious infection or fever\n* Antibody positive for Hepatitis C, HIV or TB\n* Hepatic transaminases \\> 2X normal'}, 'identificationModule': {'nctId': 'NCT00659412', 'briefTitle': 'A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course', 'orgStudyIdInfo': {'id': 'C-737'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Course A1', 'interventionNames': ['Drug: Alefacept', 'Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Course A2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Course B', 'description': 'Open-label extension', 'interventionNames': ['Drug: Alefacept', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Alefacept', 'type': 'DRUG', 'otherNames': ['Amevive, ASP0485'], 'description': 'Intramuscular', 'armGroupLabels': ['Course A1', 'Course B']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Course A1', 'Course A2', 'Course B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intramuscular', 'armGroupLabels': ['Course A2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': 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'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'D-13125', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-37075', 'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '15-337', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '62-800', 'city': 'Kalisz', 'country': 'Poland', 'geoPoint': {'lat': 51.76109, 'lon': 18.09102}}, {'zip': '30-119', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '87-100', 'city': 'Torun', 'country': 'Poland', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '02-637', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '107076', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603600', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '190068', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma US, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}