Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04132258
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2019-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of inflammatory rhinitis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Presence of inflammatory rhinitis yes/no'}], 'secondaryOutcomes': [{'measure': 'Characteristics associated with Patient-related characteristics in inflammatory rhinitis.', 'timeFrame': 'through study completion, an average of 1 year', 'description': '* Age\n* Tobacco use yes/no\n* Diabetes yes/no\n* Verneuil disease yes/no\n* Psoriasis yes/no\n* Eczema in childhood yes/no\n* Underlying pathology (type, start year)\n* Previous biotherapies and duration of exposure over the last 3 years yes/no'}, {'measure': 'Characteristics of rhinitis.', 'timeFrame': 'through study completion, an average of 1 year', 'description': '* Delays between the start of treatment and the onset of symptoms\n* Treatment under which rhinitis occurred\n* Rhinitis stage\n* Permanent or recurring, unilateral or bilateral\n* Associated functional signs (rhinorrhea, pain...)\n* Quality of Life (DLQI)\n* Presence of documented endonasal staphylococcus yes/no\n* Positivity of anti-nuclear antibodies yes/no\n* Type of treatment carried out'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammatory Rhinitis']}, 'descriptionModule': {'briefSummary': 'Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).', 'detailedDescription': 'Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. It can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by Cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. Some authors also describe associated paradoxical psoriasiform reactions or an impetigo. In our experience, this condition is more frequently found in patients treated for IBD or SPA and has a clinically characteristic fissure appearance. Thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described.\n\nThe objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).\n\nPatient recruitment will take place over a one-year period, in a multi-centre manner (Angers and Nantes University Hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruitment of patients on biotherapies that meet the inclusion criteria as exhaustively as possible.\n\n* Major patients, followed at the University Hospital of Angers and Nantes, in the dermatology, gastroenterology and rheumatology departments for chronic inflammatory diseases requiring treatment with biotherapy started at least 3 months ago.\n* Recruitment during consultations in the specialties concerned or in the day hospitals planned for the administration of treatments.\n\nTranslated with www.DeepL.com/Translator', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient (\\> 18 years of age),\n* Biotherapy treatment: anti TNF, ustekinumab, secukinumab, ixekizumab, Rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti Il1, Anti Il6,\n* Biotherapy treatment \\> 3 months,\n* Chronic inflammatory disease: psoriasis, ankylosing spondylitis (SPA), rheumatoid arthritis (RA), Crohn's disease (CD), bleeding rectocolitis (HRC)\n* No opposition to the study\n\nExclusion Criteria:\n\n* Patient under legal protection measure,\n* Refusal of the subject to participate in the study,"}, 'identificationModule': {'nctId': 'NCT04132258', 'acronym': 'RIB18', 'briefTitle': '"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': '"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"', 'orgStudyIdInfo': {'id': 'RC18_0397'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER', 'description': '(presence of certain antecedents, weight, height, current or past existence of inflammatory rhinitis) and a second by the specialist doctor (pathology at the origin of the start of biotherapy, year of beginning of treatment, previous biotherapies over the last 3 years).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}