Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00638469
Status:
UNKNOWN
Last Update Posted:
2013-11-01
First Post:
2008-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-08-03', 'releaseDate': '2017-10-27'}], 'estimatedResultsFirstSubmitDate': '2017-10-27'}}, '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': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified PASI (psoriasis area and severity index)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'VAS patient score for therapeutic effect', 'timeFrame': '12 months'}, {'measure': 'VAS patient score for severity of skin lesions', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Biologic', 'adalimumab', 'narrowband 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 additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.', 'detailedDescription': 'Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to \\< 3) for a maximum of another 6 weeks (until week 12). PASI score, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score 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 with PASI reduction of less than 75% after at least 6 weeks of 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': 'NCT00638469', 'briefTitle': 'UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab', 'orgStudyIdInfo': {'id': '19-133 ex 07/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'left/right', 'description': 'left or right body side', 'interventionNames': ['Radiation: UVB-311nm', 'Other: No treatment']}], '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']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'no UV exposure', 'armGroupLabels': ['left/right']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Peter Wolf, MD', 'role': 'CONTACT', 'email': 'peter.wolf@medunigraz.at', 'phone': '+43 316 385', 'phoneExt': '80315'}, {'name': 'Angelika Hofer, MD', 'role': 'CONTACT', 'email': 'angelika.hofer@medunigraz.at', 'phone': '+43 316 385', 'phoneExt': '13254'}, {'name': 'Peter Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Angelika Hofer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Franz Legat, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wolfgang Salmhofer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Gruber-Wackernagel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wolfgang Weger, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Graz, Department of Dermatology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Peter Wolf, MD', 'role': 'CONTACT', 'email': 'peter.wolf@medunigraz.at', 'phone': '+43 316 385', 'phoneExt': '80315'}, {'name': 'Angelika Hofer, MD', 'role': 'CONTACT', 'email': 'angelika.hofer@medunigraz.at', 'phone': '+43 316 385', 'phoneExt': '80315'}], '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'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-27', 'type': 'RELEASE'}, {'date': '2018-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz'}}}}