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SLE, and Organ Damage IndexNCT06313151

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

An observational study of SLE, and Organ Damage Index, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
SLE, and Organ Damage Index
How many people
200 participants
Where
1 siteEgypt
Study dates
10 Mar 2024to 15 Mar 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

alyaa A mohamed, doctorate contact

01007218644

aliaa.abdelhameed@med.sohag.edu.eg

mahmoud s allam, doctorate contact

01091103331

m.sobhy.allam@gmail.com

Egypt1 site, 1 recruiting
  • Sohag University

    Sohag, 82511

    alyaa A mohamed, 01007218644, aliaa.abdelhameed@med.sohag.edu.eg

    mahmoud S allam, 01091103331, m.sobhy.allam@gmail.com

    Recruiting

Other trials in Egypt

About this study

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 .

Read the 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).

Medical subject headings
Lupus Erythematosus, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria.

    Measured: wihe in 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start10 Mar 2024
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06313151
Sponsor's protocol ID
Soh-Med-24-02-02MD
Status last verified
Mar 2024
First submitted
10 Mar 2024
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of SLE, and Organ Damage Index, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact alyaa A mohamed, doctorate (01007218644, aliaa.abdelhameed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria. (time frame: wihe in 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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