NCT07374367

Brief Summary

The goal of this case control study is to detect serum isthmin-1 level in RA patient compered to healthy control . The main questions it aims to answer are: what is the serum isthmin-1 level in RA patient? what is the correlation between serum isthmin-1 and RA disease activity? what is the correlation between serum isthmin-1 level and MSUS finding in RA patients?

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started May 2026

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 Progress1%
May 2026Dec 2027

First Submitted

Initial submission to the registry

January 16, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 16, 2026

Last Update Submit

January 25, 2026

Conditions

Disease Activity

Outcome Measures

Primary Outcomes (1)

  • Detection of serum isthmin-1 level in RA patients compared to healthy controls.

    The quantitative level of Human ISM1 will be measured with a commercial enzyme-linked immunosorbent assay(ELISA) kit.

    baseline

Secondary Outcomes (1)

  • To correlate serum ISM1 levels with disease activity in RA

    baseline

Study Arms (2)

rheumatoid arthritis patient

age and sex matched healthy control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.

You may qualify if:

  • Adult patients (≥18 years old) clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.

You may not qualify if:

  • Patients less than 18 years old.
  • Patients with other autoimmune diseases.
  • Participants with active infections, malignancies or diabetes.
  • Recent hand surgery, trauma, deformity and neurological conditions affecting hand function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample of RA patients and controls to detect isthmin-1 level

Central Study Contacts

Amera I Abd el-Ghany, ass. lecturer

CONTACT

01003139319amera_i95@yahoo.com

Eman M Shawky, lecturer

CONTACT

01063489998eman202@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share