NCT06620484

Brief Summary

Evaluation of muscle state in rheumatoid arthritis patients. Application of elastography in the detection of muscle stiffness in rheumatoid arthritis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

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

First Submitted

Initial submission to the registry

August 6, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 1, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 6, 2024

Last Update Submit

September 29, 2024

Conditions

Keywords

Muscle state

Outcome Measures

Primary Outcomes (1)

  • Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us

    Baseline

Secondary Outcomes (1)

  • Application of elastography in the detection of muscle stiffness in rheumatoid arthritis patients

    Baseline

Study Arms (2)

Rheumatoid arthritis patients

Device: Musculoskeletal Ultrasound with elastography

Healthy control group

Device: Musculoskeletal Ultrasound with elastography

Interventions

Musculoskeletal Ultrasound with elastography

Healthy control groupRheumatoid arthritis patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be divided into two groups matched for age and sex : Group A: rheumatoid arthritis will include 36 participants Group B: healthy participants (control) will include 36 participants

You may qualify if:

  • Age 18:70 years
  • RA patients with positive RF And Anti ccp

You may not qualify if:

  • History of injury or operation of the lower limb and upper limbs .
  • History or clinical signs of neuromuscular disorders.
  • Patients on drugs causing myopathy or myositis
  • History of chronic diseases : kidney and liver disease
  • Diabetic patients .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8.

    PMID: 25294644BACKGROUND
  • Brennan FM, McInnes IB. Evidence that cytokines play a role in rheumatoid arthritis. J Clin Invest. 2008 Nov;118(11):3537-45. doi: 10.1172/JCI36389.

    PMID: 18982160BACKGROUND
  • Huffman KM, Jessee R, Andonian B, Davis BN, Narowski R, Huebner JL, Kraus VB, McCracken J, Gilmore BF, Tune KN, Campbell M, Koves TR, Muoio DM, Hubal MJ, Kraus WE. Molecular alterations in skeletal muscle in rheumatoid arthritis are related to disease activity, physical inactivity, and disability. Arthritis Res Ther. 2017 Jan 23;19(1):12. doi: 10.1186/s13075-016-1215-7.

    PMID: 28114971BACKGROUND
  • Londhe P, Guttridge DC. Inflammation induced loss of skeletal muscle. Bone. 2015 Nov;80:131-142. doi: 10.1016/j.bone.2015.03.015.

    PMID: 26453502BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mostafa K Khedr, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 6, 2024

First Posted

October 1, 2024

Study Start

October 1, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

October 1, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share