Rheumatoid Arthritis (RANCT07401732
Dysphagia in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA, run by Tanta University at 2 sites in Egypt.
Trial summary
The primary goal of this cross-sectional study is to assess risk factors/predictors for dysphagia in RA. The secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- flexible fiberoptic pharyngolaryngoscopy
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 Feb 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RA defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.
Who may be able to join
- Patients with Rheumatoid arthritis 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.
Who cannot join
- concomitant thyroid dysfunction.
- concomitant hypovitaminosis D.
- concomitant cancer diagnosis, pregnancy.
- jaw-related traumas, teeth, and gum diseases.
- other rheumatologic conditions
- other comorbidities.
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- other causes of TMJ arthritis, patients with TMJ, palatal or tongue congenital abnormalities, and patients who underwent TMJ injections in the last six months.
- 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.
- Any apparent causes of dysphagia other than RA.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of medicine, Tanta University
Tanta, Elgharbia, 31151
Ayman Fouad, MD
Basma ES Elmorshidy, MD
- Recruiting
Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta University
Tanta, Elgharbia, 31151
Aliaa MA Farag, MD, +201069468486, aliaa.mamdouh@med.tanta.edu.eg
About this study
Official title: Prediction of Dysphagia and Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study
The primary goal of this cross-sectional study is to assess risk factors/predictors for dysphagia in RA.
The secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and esophageal dysphagia are present among these patients.
Read more
The main questions it aims to answer are
- What are the predictors that are associated with dysphagia via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients?
- Whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with RA?
- Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- flexible fiberoptic pharyngolaryngoscopy
- Keywords
- Flexible Endoscopic Evaluations of Swallowing, Temporomandibular joint, Deglutition disorders, cricoarytenoid
- Medical subject headings
- Arthritis, Rheumatoid, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible fiberoptic pharyngolaryngoscopyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Study Model | Single Group Assignment (rheumatoid arthritis patients) Receives: Diagnostic Test: flexible fiberoptic pharyngolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.
Demonstrating the associations between the dysphagia severity scale (DSS) via flexible/fibre-optic endoscopic evaluations of swallowing (FEES) and the following:
- 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.
- 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
- 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.
- Cricoarytenoid joint dysfunction.
- Specific change in temporomandibular (TMJ) joints by cone beam CT imaging.
Measured: 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.
Secondary outcomes (2)
Demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose Joint-Affection-Induced dysphagia in patients with RA.
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.
Measured: 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.
Demonstrating whether both oropharyngeal and oesophageal dysphagia are present among patients with RA?
An upper oesophagus examination by FEES may provide a useful screening tool for oesophageal dysphagia in addition to the routine oropharyngeal and laryngeal examination.
Measured: up to 2 minutes following routine FEES.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start7 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mamdouh Abdelaziz Farag, Tanta University
- Investigators
- Aliaa MA Farag, MD, Principal investigator, Tanta University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401732
- Sponsor's protocol ID
- 36264PR772/7/24
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Dysphagia and Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07401732
- Acronym / sponsor ID
- 36264PR772/7/24
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- Flexible Endoscopic Evaluations of Swallowing, Temporomandibular joint, Deglutition disorders, cricoarytenoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this cross-sectional study is to assess risk factors/predictors for dysphagia in RA.
The secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and esophageal dysphagia are present among these patients.
The main questions it aims to answer are
- What are the predictors that are associated with dysphagia via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients?
- Whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with RA?
- Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Study Model | – | Diagnostic Test: flexible fiberoptic pharyngolaryngoscopySingle Group Assignment (rheumatoid arthritis patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.
Key inclusion criteria (2 listed)
- Patients with Rheumatoid arthritis 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.
Key exclusion criteria (9 listed)
- concomitant thyroid dysfunction.
- concomitant hypovitaminosis D.
- concomitant cancer diagnosis, pregnancy.
- jaw-related traumas, teeth, and gum diseases.
- other rheumatologic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible fiberoptic pharyngolaryngoscopyFlexible 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. | Diagnostic test | Interventional Study Model |
Primary outcome
Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.
Time frame: 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.
Demonstrating the associations between the dysphagia severity scale (DSS) via flexible/fibre-optic endoscopic evaluations of swallowing (FEES) and the following: 1. 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. 2. 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 3. 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. 4. Cricoarytenoid joint dysfunction. 5. Specific change in temporomandibular (TMJ) joints by cone beam CT imaging.
2 secondary outcomes
Demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose Joint-Affection-Induced dysphagia in patients with RA.
Time frame: 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.
Demonstrating whether both oropharyngeal and oesophageal dysphagia are present among patients with RA?
Time frame: up to 2 minutes following routine FEES.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Data is available with corresponding author on reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aliaa MA Farag, MD principal investigator
Tanta University Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa MA Farag, MD (+201069468486, aliaa.mamdouh@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.