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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82511
alyaa A mohamed, 01007218644, aliaa.abdelhameed@med.sohag.edu.eg
mahmoud S allam, 01091103331, m.sobhy.allam@gmail.com
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:
- 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.
Exclusion criteria:
- 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.
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:
- Demographic data: age, gender,sex.
- 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.
- 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).
- Conditions
- SLE, and Organ Damage Index
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted15 Mar 2024
- Study start10 Mar 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE, and Organ Damage IndexStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Abdelhameed, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06313151
- Acronym / sponsor ID
- Soh-Med-24-02-02MD
- Conditions
- SLE, and Organ Damage Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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:
- 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.
Exclusion criteria:
- 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.
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:
- Demographic data: age, gender,sex.
- 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.
- 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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria.
Time frame: wihe in 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.