Isthmin-1 as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Disease Activity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serum Isthmin-1 Level as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings
Overview
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.
Primary outcome measures
- Detection of serum isthmin-1 level in RA patients compared to healthy controls. [Time frame: baseline]
Secondary outcome measures (1)
- To correlate serum ISM1 levels with disease activity in RA [Time frame: baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07374367 · Isthmin-1, Rheumatoid ,MSUS