NCT05158400

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 Dec 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

December 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

December 12, 2021

Last Update Submit

December 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand

    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

Study Arms (1)

Cases

EXPERIMENTAL
Radiation: Ultrasound

Interventions

UltrasoundRADIATION

Ultrasound examination 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

  • 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
  • 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 Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

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

December 12, 2021

First Posted

December 15, 2021

Study Start

December 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

December 15, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations