The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients

March 10, 2024 updated by: Aliaa Abdelhameed, Sohag University
The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis .

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study will include 200 systemic lupus patient attending Sohag University Hospital from march 2024 to march 2025 in Rheumatology Department.

The patients included in the study will be classified as SLE patient according to 2019 ACR/EULAR classification criteria.

Inclusion criteria:

  1. Patient age is above 16 years old
  2. Patient is classified as SLE patient according to 2019 ACR/EULAR classification criteria
  3. patient with disease duration more than 6 month.

Exclusion criteria:

  1. Patient with drug-induced lupus and those with systemic sclerosis or dermatomyositis overlap syndromes .
  2. patient with disease duration less than 6 month will be excluded.

Methods:

All patient will be selected randomly and undergo a complete history taking and physical examination, The data will be collected and analyzed as the following:

  1. Demographic data: age, gender,sex.

  2. Clinical data:

    O Age of disease onset ,disease duration, time of disease onset, organs involved , O presence of hypertension, hyperlipidemia, or diabetes, O drugs administration of hydroxychloroquine , azathioprine , cyclophosphamide pulse, cyclosporine, mycophenolate mofetil, prednisolone, and use of pulses of methylprednisolone.

  3. disease activity measured by SLEDAI.

Laboratory results:

routine investigations: white cell count, hemoglobin, platelet,serum creatinine, ALT ,AST and urine analysis.

oAntinuclear antibody (ANA) by immunofluorescence and its pattern oANA profile

  • Complement C3,C4.
  • anticardiolipin antibody (ACA), lupus anticoagulant (LA). O Further investigation will be customized to the patient according to their clinical history and examination like abdominal ultra sound,24 hours urine protein ,glumerular filteration rate ,renal biopsy, x-ray on chest or vertebral colon, CT chest or brain, MRI brain , ECG, echo cardiography.

The organ damage assessment with the SLICC/ACR Damage Index (SDI) contains items that represent permanent, irreversible damage in a lupus patient. Items should be present for at least 6 months with the exception that manifestations such as myocardial infarction and stroke are recorded once they occur. Damage is defined for 12 organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1), and malignancies (0-2). Damage over time can only be stable or increase, theoretically to a maximum of 47 points(6).

Study Type

Observational

Enrollment (Estimated)

200

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

Study Locations

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

Sampling Method

Probability Sample

Study Population

The study will include 200 systemic lupus patient attending Sohag University Hospital from march 2024 to march 2025 in Rheumatology Department.

The patients included in the study will be classified as SLE patient according to 2019 ACR/EULAR classification criteria.

Description

Inclusion Criteria:

  1. Patient age is above 16 years old
  2. Patient is classified as SLE patient according to 2019 ACR/EULAR classification criteria
  3. patient with disease duration more than 6 month.

Exclusion Criteria:

  1. Patient with drug-induced lupus and those with systemic sclerosis or dermatomyositis overlap syndromes .
  2. patient with disease duration less than 6 month will be excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria.
Time Frame: wihe in 18 months
wihe in 18 months

Collaborators and Investigators

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

Sponsor

Sohag University

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)

March 10, 2024

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-02-02MD

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.

Clinical Trials on SLE, and Organ Damage Index

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe