NCT04961853

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Patient's With Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of Ultrasound and MRI in Rheumatoid Arthritis of the hand

    determine the diagnostic value and associated weakness and strength aspects of hand ultrasound versus MRI in patients with rheumatoid arthritis, particularly in early disease.

    3 months

Study Arms (1)

Cases

EXPERIMENTAL
Radiation: Ultrasound and MRI

Interventions

Ultrasound and MRIRADIATION

Ultrasound examination and magnetic resonance imaging on the hand

Cases

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult-onset disease.
  • Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.

You may not qualify if:

  • Any patient with any collagen disease rather than Rheumatoid arthritis.
  • Patients with joints deformities.
  • Patient's with implanted metal clips or wires or artificial pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 31898524BACKGROUND

  • 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.

    PMID: 23230093BACKGROUND

  • Hodgson RJ, O'Connor P, Moots R. MRI of rheumatoid arthritis image quantitation for the assessment of disease activity, progression and response to therapy. Rheumatology (Oxford). 2008 Jan;47(1):13-21. doi: 10.1093/rheumatology/kem250. Epub 2007 Nov 28.

    PMID: 18045811BACKGROUND

  • 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.

    PMID: 21862794BACKGROUND

MeSH Terms

Interventions

High-Energy Shock WavesMagnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Fady B A, resident

CONTACT

01091799614fady011123@med.sohag.edu.eg

Nahla M A, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Diagnostic and Interventional Radiology, Sohag university

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 14, 2021

Study Start

August 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)