Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:02 AM
Study NCT ID:
NCT07401732
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dysphagia in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.', 'timeFrame': 'The assessment of dysphagia severity via FEES typically will take nearly 25 minutes. The duration of clinical, laboratory, and radiological tests will take 1 to 2 days and may vary depending on the specific circumstances.', 'description': "Demonstrating the associations between the dysphagia severity scale (DSS) via flexible/fibre-optic endoscopic evaluations of swallowing (FEES) and the following:\n\n1. Active disease by disease activity score in 28 joints with C-reactive protein (DAS28-CRP ): low if DAS28-CRP score was less than 3.2, moderate if the score between 3.2 and 5.1, or high if the score \\> 5.1.\n2. RA patient's malfunction by Modified Health Assessment Questionnaire (MHAQ): mild functional loss if score less than 1.3, moderate if score between 1.3 and 1.8, severe loss if \\> 1.8\n3. Temporomandibular dysfunction: mild TMJ dysfunction if score from 20 to 40, moderate dysfunction if score from 45 to 65 and severe TMJ dysfunction if the score from 70 to 100.\n4. Increased serum thyroid-stimulating hormone (TSH) \\> 5 mU/L\n5. Erosion in temporomandibular (TMJ) and/or cricoarytenoid (CAJ) joints by cone beam CT imaging."}], 'secondaryOutcomes': [{'measure': 'Demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose Joint-Affection-Induced dysphagia in patients with RA.', 'timeFrame': 'Assessment of rheumatoid arthritis patients by FEES will take 10 to 25 minutes. The duration may vary depending on the specific circumstances and the complexity of the assessment.', 'description': 'Flexible Endoscopic Evaluations of Swallowing (FEES) will be used to examine the nose, throat, and airway to diagnose possible causes of dysphagia. It is a flexible process that may be applied to a variety of situations and objectives (named as flexible pharyngolaryngoscopy). Following the routine oropharyngeal examination, its versatility can enable it to be used as a laryngoscope for examining the larynx and adjacent regions.'}, {'measure': 'Demonstrating whether both oropharyngeal and oesophageal dysphagia are present among patients with RA?', 'timeFrame': 'up to 2 minutes following routine FEES.', 'description': 'An upper oesophagus examination by FEES may provide a useful screening tool for oesophageal dysphagia in addition to the routine oropharyngeal and laryngeal examination.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flexible Endoscopic Evaluations of Swallowing', 'Temporomandibular joint', 'Deglutition disorders', 'cricoarytenoid'], 'conditions': ['Rheumatoid Arthritis (RA']}, 'descriptionModule': {'briefSummary': 'The primary goal of this cross-sectional study is to assess risk factors/predictors for dysphagia severity in RA.\n\nThe secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and esophageal dysphagia are present among these patients.\n\nThe main questions it aims to answer are\n\n* What are the predictors that are associated with dysphagia severity via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients?\n* Whether flexible fiberoptic pharyngolaryngoscopy can diagnose joint-affection-induced dysphagia in patients with RA?\n* Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?', 'detailedDescription': 'This cross-sectional study will comprise RA patients during their visits to inpatient and outpatient clinics. The inclusion criterion is patients with RA defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria. Patients aged above 18 years old, well-orientated, and cooperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with RA defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Rheumatoid arthritis defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.\n* Patients aged above 18 years old, well-orientated, and cooperative.\n\nExclusion Criteria:\n\n* concomitant cancer diagnosis, pregnancy.\n* jaw-related traumas, teeth and gum diseases.\n* other rheumatologic conditions\n* other comorbidities.\n* other causes of TMJ arthritis, patients with TMJ, palatal or tongue congenital abnormalities, and patients who underwent TMJ injections in the last six months.\n* Patients with any language disorders or intellectually handicapped (as certain questions depend on the patient's ability to comprehend and express their emotions regarding their issue) and patients with anatomical anomalies impeding the functionality of flexible nasofibroscopy.\n* Any apparent causes of dysphagia other than RA."}, 'identificationModule': {'nctId': 'NCT07401732', 'briefTitle': 'Dysphagia in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Prediction of Dysphagia Severity and Diagnosis of Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '36264PR772/7/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interventional Study Model', 'description': 'Single Group Assignment (rheumatoid arthritis patients)', 'interventionNames': ['Diagnostic Test: flexible fiberoptic pharyngolaryngoscopy']}], 'interventions': [{'name': 'flexible fiberoptic pharyngolaryngoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Flexible Endoscopic Evaluations of Swallowing (FEES) will be used to examine the nose, throat, and airway to diagnose possible causes of dysphagia. The dysphagia severity scale via FEES will be scored. It is a flexible process that may be applied to a variety of situations and objectives (named as flexible pharyngolaryngoscopy). Following the routine oropharyngeal examination, its versatility can enable it to be used as a laryngoscope for examining the larynx and adjacent regions.', 'armGroupLabels': ['Interventional Study Model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31151', 'city': 'Tanta', 'state': 'Elgharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman Fouad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'El Sayed M Rageh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Basma ES Elmorshidy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'MennatAllah EA Gahgah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heba AH Hanout, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dina HM Abdella, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lina Hablas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aliaa MA Farag, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nehal Abdelaziz, Demonstrator Oral Radiology de', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '31151', 'city': 'Tanta', 'state': 'Elgharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Aliaa MA Farag, MD', 'role': 'CONTACT', 'email': 'aliaa.mamdouh@med.tanta.edu.eg', 'phone': '+201069468486'}], 'facility': 'Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Aliaa MA Farag, MD', 'role': 'CONTACT', 'email': 'aliaa.mamdouh@med.tanta.edu.eg', 'phone': '+201069468486'}, {'name': 'Ayman Fouad, MD', 'role': 'CONTACT', 'email': 'aymanfouadtanta@med.tanta.edu.eg', 'phone': '+20 10 04398763'}], 'overallOfficials': [{'name': 'Aliaa MA Farag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is available with corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Aliaa Mamdouh Abdelaziz Farag', 'investigatorAffiliation': 'Tanta University'}}}}