NCT07396194

Brief Summary

The goal of this observational study is to measure the serum level of cytokines IL-17, IL-38,IL-41, and gene expression of HLA-B27 gene in ankylosing spondylitis patients and healthy control group. The main question it aims to answer is: Does the disease activity, severity, serum level of cytokines (IL-17, IL-38, and IL-41) are affected by the HLA-b27 gene positivity? Researchers will compare the serum level of cytokines IL-17, IL-38,IL-41, and gene expression of HLA-B27 gene in ankylosing spondylitis patients and healthy control group to see if there significant differences in serum levels of interleukins 17, 38, 41 in AS patients and healthy control group. .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

February 1, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Interleukin 17Interleukin 38Interleukin 41HLA- B27 gene

Outcome Measures

Primary Outcomes (5)

  • collection of blood samples from paticipants

    from March 2026 to August 2026

  • measurement of serum level of Interleukin 17 in participants

    From September 2026 to October 2026

  • Measurement of serum level of Interleukin 38 in participants

    from September 2026 to October 2026

  • measurement of serum level of Interleukin 41 in participants

    from September 2026 to October 2026

  • measurement of gene expression of HLA- B27 gene in participants

    from October 2026 to December 2026

Study Arms (2)

Cases

Patients with Ankylosing spondylitis

Healthy Controls

Participants Without Ankylosing spondylitis

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the outpatient clinics of Rheumatology and Rehabilitation Department, Sohag University Hospitals.

You may qualify if:

  • patients who are diagnosed clinically as ankylosing spondylitis (both active or stable), of either sex , who met the Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis.

You may not qualify if:

  • Patients with any autoimmune disorder, chronic illnesses as diabetes mellitus, acute and chronic infectious diseases, malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Central Study Contacts

Alaa Ezzat Ahmed, Assisstant lecturer

CONTACT

Dina Hamada Mohamed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

1. to avoid the reuse of data for unfair commercial purposes 2. to avoid the reuse of data for purposes that had not been approved by participants