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Isthmin-1 as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings

Serum Isthmin-1 Level as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07374367
Enrollment
66
Registered
2026-01-28
Start date
2026-05-01
Completion date
2027-12-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease Activity

Brief summary

The goal of this case control study is to detect serum isthmin-1 level in RA patient compered to healthy control . The main questions it aims to answer are: what is the serum isthmin-1 level in RA patient? what is the correlation between serum isthmin-1 and RA disease activity? what is the correlation between serum isthmin-1 level and MSUS finding in RA patients?

Detailed description

Rheumatoid arthritis is a chronic autoimmune disease characterized by persistent synovitis, pannus formation, and bone erosion leading to joint damage and functional impairment . It manifests as a symmetrical polyarthritis predominantly affecting the small joints of the hands, the earliest and most severely affected site in RA. A total of 94% of the patients suffered from at least one hand or wrist symptom after 2-4 years of disease duration. The most frequently described symptoms were pain, stiffness of the hand, muscle weakness, paresthesia, and a limited fist, which significantly impair their daily hand function. Current monitoring tools, including ESR, CRP, and DAS-28, lack sensitivity for subclinical synovitis. These limitations underscore the need for novel biomarkers integrating systemic inflammatory activity with joint pathology and functional status. Isthmin-1 (ISM1), a multifunctional adipokine that suppresses NF-κB pathway, thereby reducing pro-inflammatory cytokine production and promoting tissue repair . This mechanism holds relevance in RA, where aberrant NF-κB activation drives synovitis and Th17-mediated immune responses . Its observed reduction in active RA signifies a loss of endogenous anti-inflammatory counter-regulation, establishing ISM1 as a promising biomarker for disease activity monitoring . Musculoskeletal ultrasound (MSUS) provides superior sensitivity compared to physical examination for detecting synovitis (. MSUS findings correlate with structural damage and functional decline, making it a valuable tool for monitoring disease impact on hand joints . This study investigates correlations between serum ISM1 levels, MSUS findings, and hand function to identify biological links for novel RA therapies that preserve joint function and enhance quality of life.

Interventions

None listed

Sponsors

Amera Imam Abdel - Ghany Ahmed
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

-Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.

Exclusion criteria

* Patients less than 18 years old. * Patients with other autoimmune diseases. * Participants with active infections, malignancies or diabetes. * Recent hand surgery, trauma, deformity and neurological conditions affecting hand function

Design outcomes

Primary

MeasureTime frameDescription
Detection of serum isthmin-1 level in RA patients compared to healthy controls.baselineThe quantitative level of Human ISM1 will be measured with a commercial enzyme-linked immunosorbent assay(ELISA) kit.

Secondary

MeasureTime frameDescription
To correlate serum ISM1 levels with disease activity in RAbaselinethrough clinical and acute phase reactant

Contacts

CONTACTAmera I Abd el-Ghany, ass. lecturer
amera_i95@yahoo.com01003139319
CONTACTEman M Shawky, lecturer
eman202@aun.edu.eg01063489998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026