Disease ActivityNCT07374367
Isthmin-1 as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings
An observational study of Disease Activity, run by Amera Imam Abdel - Ghany Ahmed.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease Activity
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
Who may be able to join
- -Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serum Isthmin-1 Level as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings
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?
Read the 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.
- Conditions
- Disease Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis patient | Not described | |
| age and sex matched healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of serum isthmin-1 level in RA patients compared to healthy controls.
The quantitative level of Human ISM1 will be measured with a commercial enzyme-linked immunosorbent assay(ELISA) kit.
Measured: baseline
Secondary outcomes (1)
To correlate serum ISM1 levels with disease activity in RA
through clinical and acute phase reactant
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amera Imam Abdel - Ghany Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amera Imam Abdel - Ghany Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374367
- Sponsor's protocol ID
- Isthmin-1, Rheumatoid ,MSUS
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Isthmin-1 Level as a Biomarker of Disease Activity in Rheumatoid Arthritis: Correlation With Musculoskeletal Ultrasound Findings
- ClinicalTrials.gov ID
- NCT07374367
- Acronym / sponsor ID
- Isthmin-1, Rheumatoid ,MSUS
- Conditions
- Disease Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Amera Imam Abdel - Ghany AhmedUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis patient | – | – |
| age and sex matched healthy control | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
Key inclusion criteria (1 listed)
- -Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of serum isthmin-1 level in RA patients compared to healthy controls.
Time frame: baseline
The quantitative level of Human ISM1 will be measured with a commercial enzyme-linked immunosorbent assay(ELISA) kit.
1 secondary outcome
To correlate serum ISM1 levels with disease activity in RA
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease Activity, run by Amera Imam Abdel - Ghany Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amera I Abd el-Ghany, ass. lecturer (01003139319, amera_i95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of serum isthmin-1 level in RA patients compared to healthy controls. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.