NCT06562049

Brief Summary

Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite

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
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Start

First participant enrolled

August 15, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 17, 2024

Last Update Submit

August 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • bone erosion

    erosions in carpal bones and MCP 2,5 in both hands

    max 1 year

Study Arms (3)

cases

rheumatoid arthriris patients

Radiation: musculoskeletal ultrasound

control

systemic lupus patients

Radiation: musculoskeletal ultrasound

controls

healthy controls

Radiation: musculoskeletal ultrasound

Interventions

musculoskeletal ultrasound on both hands

casescontrolcontrols

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.\[8\] 2. SLE patients fulfilled the 2019 ACR\\EULAR classification criteria for SLE.\[9\] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent

You may qualify if:

  • \. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.\[8\] 2. SLE patients fulfilled the 2019 ACR\\EULAR classification criteria for SLE.\[9\] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent.

You may not qualify if:

  • \. Age below 18 years and above 60 years. 2. Uncooperative patients. 3. Patient not able and willing to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (3)

  • Sommer OJ, Kladosek A, Weiler V, Czembirek H, Boeck M, Stiskal M. Rheumatoid arthritis: a practical guide to state-of-the-art imaging, image interpretation, and clinical implications. Radiographics. 2005 Mar-Apr;25(2):381-98. doi: 10.1148/rg.252045111.

    PMID: 15798057BACKGROUND
  • Ejbjerg BJ, Vestergaard A, Jacobsen S, Thomsen H, Ostergaard M. Conventional radiography requires a MRI-estimated bone volume loss of 20% to 30% to allow certain detection of bone erosions in rheumatoid arthritis metacarpophalangeal joints. Arthritis Res Ther. 2006;8(3):R59. doi: 10.1186/ar1919. Epub 2006 Mar 15.

    PMID: 16542505BACKGROUND
  • Mottonen TT. Prediction of erosiveness and rate of development of new erosions in early rheumatoid arthritis. Ann Rheum Dis. 1988 Aug;47(8):648-53. doi: 10.1136/ard.47.8.648.

    PMID: 3137902BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

abeer A abdelaal, Resident

CONTACT

ahmed M mahrous, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident of Physical medicine, Rheumatology and Rehabilitation Department

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

August 15, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations