Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT05674695
Status:
RECRUITING
Last Update Posted:
2023-01-06
First Post:
2023-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D000069444', 'term': 'Omalizumab'}, {'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'C000613732', 'term': 'upadacitinib'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and 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'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of adverse events', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'For each drug or drug type'}, {'measure': 'Relative rate of adverse events', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Compared to a standard drug ( such as cyclosporine). Crude and adjusted'}], 'secondaryOutcomes': [{'measure': 'Change in Eczema Area and Severity Index (EASI)', 'timeFrame': 'Change between baseline and 6 months', 'description': 'EASI is used to measure the extent (area) and severity of atopic eczema.The minimum EASI score is 0 and the maximum EASI score is 72. A higher score means more severe or extended disease.'}, {'measure': 'Change in Patient Oriented Eczema Measure (POEM)', 'timeFrame': 'Change between baseline and 6 months', 'description': 'The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient. It ranges from 0 to 28, with higher scores meaning worse disease.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.\n\nThe main objectives are:\n\n1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).\n2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.\n\nSecondary objectives are:\n\n1. To assess short and long-term safety of topical therapies for atopic eczema.\n2. To assess effectiveness of different methods of care, including patient training.\n3. To describe atopic dermatitis comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one).\n2. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.\n3. Willingness to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Insufficient understanding of the study by the patient and/or parent/guardian.\n2. Patients who are currently participating in a randomised clinical trial.\n3. Intention to move to a different geographical area in a short-term (next 3 months).'}, 'identificationModule': {'nctId': 'NCT05674695', 'acronym': 'BIOBADATOP', 'briefTitle': 'Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Academia Española de Dermatología'}, 'officialTitle': 'Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy', 'orgStudyIdInfo': {'id': 'FAE-ATO-2018-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ciclosporin', 'type': 'DRUG', 'otherNames': ['Methotrexate', 'Dupilumab', 'Corticosteroids', 'Omalizumab', 'Baricitinib', 'Upadacitinib', 'Tralokimumab', 'Topical corticosteroids'], 'description': 'Any systemic drug used for atopic dermatitis in clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Manuel Carrascosa, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Francisco Silvestre Salvador', 'role': 'CONTACT'}], 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana María Gimenez-Arnau', 'role': 'CONTACT'}], 'facility': 'Hospital del Mar IMIM', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Las Palmas', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alicia González Quesada, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Gran Canaria Dr Negrín', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo De la Cueva Dobao', 'role': 'CONTACT'}], 'facility': 'Hospital Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Chicharro Manso', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pontevedra', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ángeles Flórez', 'role': 'CONTACT'}], 'facility': 'Complexo Hospitalario Universitario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mercedes Rodríguez Älvarez', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario y Politécnico la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Yolanda Gilaberte', 'role': 'CONTACT'}], 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Ignacio Garcia-Doval', 'role': 'CONTACT', 'email': 'investigacion@aedv.es', 'phone': '34915 44 62 84'}, {'name': 'Miguel Angel Descalzo Gallego', 'role': 'CONTACT', 'phone': '34915 44 62 84'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Academia Española de Dermatología', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}