ClinicalTrials.gg
Not yet recruitingNCT07648836Updated Jul 21, 2026

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

An observational study in Ankylosing Spondylitis and Psoriasis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Ankylosing Spondylitis
  • Psoriasis

Keywords

  • Ankylosing spondylitis
  • psoriasis
  • biomarker
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In context

Spondylitis, Ankylosing

531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.

This study's planned enrollment of 90 is below the median of 202 across 214 observational studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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,

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • psoriatic arthritis patients

    Diagnostic Test: IL 41

  • Ankylosing spondylitis Patients

    AS diagnosed according to the modified New York criteria

    Diagnostic Test: IL 41

  • control

    apparentely healthy controls

    Diagnostic Test: IL 41

Interventions

  • Diagnostic testIL 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.

06

What researchers measure

Primary outcomes

  1. • Serum IL41 differences among AS, PsA, and controls

    Time frame: 1month

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Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 15, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Dec 30, 2026
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07648836
Lead sponsor
Assiut University
Responsible party
Sara Farrag Ahmed Mohamed (lecturer of rheumatology and rehabilitation, Assiut University) — Principal investigator
First posted
Jun 15, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 21, 2026

Study contacts

Sara Farrag lecturer of rheumatology and rehabilitation, lecturer
Contact
sara_farrag@aun.edu.eg
+01097767735

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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