NCT05570513

Brief Summary

Assess the impact of rs2201841 and rs2275913 single nucleotide polymorphism of host genes IL-23R and IL-17A respectively on susceptibility of rheumatoid arthritis . Determine serum levels of IL-23 and IL-17A using ELISA test to investigate their correlation to rheumatoid arthritis disease activity . Compare the 4 biomarkers IL-23R and IL-17A genetic polymorphism and levels of IL-23 and IL-17A as predictors of rheumatoid arthritis susceptibility and disease activity .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Aug 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

September 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2026

Expected
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 27, 2022

Last Update Submit

October 4, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • serum levels of IL23 and IL17A and its Relation to Rheumatoid Arthritis susceptibility and activity

    3 years

Eligibility Criteria

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

90 subjects (45 rheumatoid arthritis patients and 45 healthy control)

You may qualify if:

  • A total of 45 Patients fulfilling the 2010 Classification Criteria of the American college of Rheumatology/European League against Rheumatism (ACR / EULAR) will be included in the study.
  • The patients will be recruited from department of Physical medicine, Rheumatology \& Rehabilitation, Assiut University Hospital.

You may not qualify if:

  • Patients with other connective tissue diseases (e.g. SLE, systemic sclerosis (SS), BD,...etc), associated autoimmune diseases, chronic liver or kidney diseases, or genetic diseases will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Asmaa Salah

CONTACT

01032130812asmaa.elprins@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at Medical Microbiology and Immunology Faculty of Medicine, Assiut university

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 6, 2022

Study Start

August 4, 2023

Primary Completion

August 4, 2025

Study Completion (Estimated)

August 4, 2026

Last Updated

October 6, 2022

Record last verified: 2022-09