Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

July 19, 2026 updated by: Sara Farrag Ahmed Mohamed, Assiut University

Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis and Their Association With Inflammatory Markers and Disease Activity

Psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are chronic inflammatory diseases within the spectrum of spondyloarthritis, characterized by immune-mediated inflammation and progressive functional impairment. Meteorin-like protein (Metrnl) is a novel adipomyokine with potential immunomodulatory and anti-inflammatory properties; however, its role in spondyloarthritis remains incompletely understood. This study aims to evaluate serum Metrnl levels in patients with PsA and AS compared with healthy controls and to investigate their association with disease activity, inflammatory markers, and clinical manifestations. The findings may provide insights into the potential role of Metrnl as a biomarker of disease activity and inflammation in spondyloarthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are chronic inflammatory disorders within the spectrum of spondyloarthritis, characterized by immune-mediated involvement of the axial skeleton, peripheral joints, and entheses. Despite advances in understanding their pathogenesis, the precise molecular mechanisms underlying disease activity and progression remain incompletely defined, highlighting the need for novel biomarkers and therapeutic targets.

Cytokines play a central role in the pathophysiology of spondyloarthritis by regulating inflammatory pathways and immune responses. Recently, attention has shifted toward newly identified cytokine-like proteins with immunometabolic functions, including meteorin-like protein (Metrnl), also referred to as interleukin-41. Metrnl is an adipomyokine expressed in various tissues, including skeletal muscle and adipose tissue, and is involved in immune regulation and inflammatory processes.

Emerging evidence suggests that Metrnl exerts dual immunomodulatory effects, contributing to both pro- and anti-inflammatory pathways depending on the disease context. It has been shown to influence macrophage activation and cytokine production, thereby playing a role in immune homeostasis (5,6). In addition, recent studies have demonstrated a potential association between circulating Metrnl levels and disease activity in inflammatory conditions, including ankylosing spondylitis.

However, data regarding the role of Metrnl in psoriatic arthritis are scarce, and comparative studies between AS and PsA are lacking. Therefore, this study aims to evaluate serum Metrnl levels in patients with ankylosing spondylitis and psoriatic arthritis and to investigate their association with disease activity and inflammatory markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sara Farrag lecturer of rheumatology and rehabilitation, lecturer
  • Phone Number: +01097767735
  • Email: sara_farrag@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

AS diagnosed according to the modified New York criteria, while PsA diagnosed based on the CASPAR criteria,

Description

Inclusion Criteria:

  • patients diagnosed with ankylosing spondylitis (AS)and psoriatic arthritis (PsA), in addition to age- and sex-matched healthy controls.

AS diagnosed according to the modified New York criteria, while PsA was diagnosed based on the CASPAR criteria.

Exclusion Criteria:

Patients under the age of 18 years, patients with other autoimmune diseases, diabetes mellitus, chronic kidney or liver disease, active infection, or malignancy were excluded to avoid confounding factors affecting inflammatory markers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
psoriatic arthritis patients
Diagnostic test: IL 41
Serum levels of meteorin-like protein (Metrnl) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.
Ankylosing spondylitis Patients
AS diagnosed according to the modified New York criteria
Diagnostic test: IL 41
Serum levels of meteorin-like protein (Metrnl) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.
control
apparentely healthy controls
Diagnostic test: IL 41
Serum levels of meteorin-like protein (Metrnl) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
• Serum IL41 differences among AS, PsA, and controls
Time Frame: 1month
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFA AS-Psa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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