Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT03746860
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1508}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety analysis: Number of patients with at least one Adverse Event', 'timeFrame': '1 year', 'description': 'Number of patients with at least one Adverse Events related to ACARIZAX®.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergy', 'Allergic Rhinitis', 'Allergic Asthma', 'House Dust Mite', 'Immunotherapy'], 'conditions': ['Allergic Rhinitis Due to House Dust Mite', 'Allergic Asthma Due to Dermatophagoides Farinae', 'Allergic Asthma Due to Dermatophagoides Pteronyssinus']}, 'descriptionModule': {'briefSummary': 'Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (\\>18 years) with house dust mite allergy over a period of 12 months.', 'detailedDescription': "Condition:\n\n* persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication\n* HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis.\n\nPatients are only included in the study after the decision for treatment with ACARIZAX® has already been made, and only with the objective of documenting data that reflects the treatment and its safety under 'real life' conditions. Accordingly, only examinations and inquiries conforming to routine practice are conducted and documented.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent\n\nExclusion Criteria:\n\n* Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).'}, 'identificationModule': {'nctId': 'NCT03746860', 'acronym': 'CARIOCA', 'briefTitle': 'N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France', 'orgStudyIdInfo': {'id': 'NI-MT-05'}, 'secondaryIdInfos': [{'id': 'ID-RCB:2017-A02668-45', 'type': 'OTHER', 'domain': 'Comité de Protection des Personnes SUD MEDITERRANNEE IV'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tablet, Dispersible', 'type': 'DRUG', 'otherNames': ['ACARIZAX 12 SQ-HDM', 'Standardised allergen extract from house dust mite'], 'description': '1 tablet/day with 12 SQ-HDM per lyo-tablet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pascal DEMOLY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ITEC Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}