Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus

June 8, 2023 updated by: Nehal Abdelbasset Ahmed, Sohag University

systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.

Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.

SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies.

Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.

So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Osama S Daifallah, Associate Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University hospitals
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.

Exclusion Criteria:

  • any patient with any collagen disease other than SLE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations
Time Frame: 6 months

the study will evaluate the titre of Anti KU

antibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

May 27, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-05-05MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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