Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2026-01-01 @ 8:53 PM
Study NCT ID:
NCT00638261
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary UVB-311nm and Adalimumab in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified PASI (psoriasis area and severity index)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Patient visual analogue score (VAS) for therapeutic effect', 'timeFrame': '12 months'}, {'measure': 'Patient VAS for severity of skin lesions', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Biologic', 'Adalimumab', 'Narrow-band UVB', 'phototherapy', 'half-side comparison'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.', 'detailedDescription': 'Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \\< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \\> 90%, \\> 75% and/or 50% between body sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psoriasis patients who are scheduled for treatment with adalimumab.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* History of skin cancer\n* Presence of or history of malignant skin tumors\n* Dysplastic melanocytic nevus syndrome\n* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)\n* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis\n* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others\n* General poor health status'}, 'identificationModule': {'nctId': 'NCT00638261', 'briefTitle': 'Primary UVB-311nm and Adalimumab in Psoriasis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis', 'orgStudyIdInfo': {'id': '19-134 ex 07/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'left/right', 'description': 'left or right body side', 'interventionNames': ['Radiation: UVB-311nm']}], 'interventions': [{'name': 'UVB-311nm', 'type': 'RADIATION', 'otherNames': ['narrow-band UVB radiation'], 'description': 'UVB-311nm radiation given 3 times a week to one randomized body-half', 'armGroupLabels': ['left/right']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz, Department of Dermatology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Peter Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Bioimmunotherapy', 'investigatorFullName': 'Peter Wolf, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}