Ankylosing SpondylitisNCT07648836
Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
An observational study of Ankylosing Spondylitis and Psoriasis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Psoriasis
- What is being tested?
- IL 41
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AS diagnosed according to the modified New York criteria, while PsA diagnosed based on the CASPAR criteria,
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sara Farrag lecturer of rheumatology and rehabilitation, lecturer contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankylosing Spondylitis, Psoriasis
- Being tested
- IL 41
- Keywords
- Ankylosing spondylitis, psoriasis, biomarker
- Medical subject headings
- Spondylitis, Ankylosing, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL 41Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| psoriatic arthritis patients | Not described Receives: Diagnostic Test: IL 41 | |
| Ankylosing spondylitis Patients | AS diagnosed according to the modified New York criteria Receives: Diagnostic Test: IL 41 | |
| control | apparentely healthy controls Receives: Diagnostic Test: IL 41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Serum IL41 differences among AS, PsA, and controls
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Farrag Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648836
- Sponsor's protocol ID
- SFA AS-Psa
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Gao Z, Sun T, Zhang S, Yang S, Zheng M, Shen H. Meteorin-like/Metrnl, a novel secreted protein implicated in inflammation, immunology, and metabolism: A comprehensive review of preclinical and clinical studies. Front Immunol. 2023 Feb 24;14:1098570. doi: 10.3389/fimmu.2023.1098570. eCollection 2023.
PubMed 36911663
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis and Their Association With Inflammatory Markers and Disease Activity
- ClinicalTrials.gov ID
- NCT07648836
- Acronym / sponsor ID
- SFA AS-Psa
- Conditions
- Ankylosing Spondylitis, Psoriasis
- Keywords
- Ankylosing spondylitis, psoriasis, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jun 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| psoriatic arthritis patients | – | Diagnostic Test: IL 41 |
| Ankylosing spondylitis Patients | – | Diagnostic Test: IL 41AS diagnosed according to the modified New York criteria |
| control | – | Diagnostic Test: IL 41apparentely healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AS diagnosed according to the modified New York criteria, while PsA diagnosed based on the CASPAR criteria,
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL 41Serum 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. | Diagnostic test | Ankylosing spondylitis Patients, control, psoriatic arthritis patients |
Primary outcome
• Serum IL41 differences among AS, PsA, and controls
Time frame: 1month
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 21 Jul 2026.
- Results publication: PubMed 36911663Li Z, Gao Z, Sun T, Zhang S, Yang S, Zheng M, Shen H. Meteorin-like/Metrnl, a novel secreted protein implicated in inflammation, immunology, and metabolism: A comprehensive review of preclinical and clinical studies. Front Immunol. 2023 Feb 24;14:1098570. doi: 10.3389/fimmu.2023.1098570. eCollection 2023.
- 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.
Sara Farrag lecturer of rheumatology and rehabilitation, lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Psoriasis, run by Assiut University.
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 2 inclusion and 1 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 21 Jul 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 Sara Farrag lecturer of rheumatology and rehabilitation, lecturer (+01097767735, sara_farrag@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Serum IL41 differences among AS, PsA, and controls (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07648836, which also lists 1 linked publication.
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 21 Jul 2026.