- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158400
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.
If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.
Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fady B A, resident
- Phone Number: 01091799614
- Email: fady011123@med.sohag.edu.eg
Study Contact Backup
- Name: Nahla M A, assistant professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
Contact:
- Osama R ElSherif, dean of the faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult-onset disease.
- Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.
Exclusion Criteria:
- Any patient with any collagen disease rather than Rheumatoid arthritis.
- Patients with joints deformities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cases
|
Ultrasound examination on the hand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand
Time Frame: 3 months
|
detecting hand ultrasound findings in 30 patients with clinical manifestations suggesting Rheumatoid Arthritis (including synovial thickening, joint effusion, tenosynovitis, bone erosions) particularly in early disease activity, reporting the collected data to assess aspects of strength and weakness of ultrasound use in those patients
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kaeley GS, Bakewell C, Deodhar A. The importance of ultrasound in identifying and differentiating patients with early inflammatory arthritis: a narrative review. Arthritis Res Ther. 2020 Jan 2;22(1):1. doi: 10.1186/s13075-019-2050-4.
- Tan YK, Ostergaard M, Conaghan PG. Imaging tools in rheumatoid arthritis: ultrasound vs magnetic resonance imaging. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii36-42. doi: 10.1093/rheumatology/kes329.
- Rowbotham EL, Grainger AJ. Rheumatoid arthritis: ultrasound versus MRI. AJR Am J Roentgenol. 2011 Sep;197(3):541-6. doi: 10.2214/ajr.11.6798.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-12-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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