Systemic Lupus Erythematosus (SLE)NCT07350772
It is an Observational Study That Compare Prognosis of Typical and Atypical Systemic Lupus Erythematosus Presentation
An observational study of Systemic Lupus Erythematosus (SLE), run by Sohag University at 1 site in Egypt.
Trial summary
Atypical presentations of SLE including unusual initial symptoms, predominant organ involvement, late-onset disease and ANA-negative remain poorly characterized. These forms are often associated with delayed diagnosis and potentially worse clinical outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 400 patients diagnosed according to SLICC classification criteria as systemic lupus erythematosus[13] including 3oo patients with typical common SLE presentation and 100 patients with atypical presentation as rare manifestations,ANA negative lupus, late onset lupus.Patients will be collected from Rheumatology outpatient clinic - Sohag University Hospital.
Who may be able to join
- Patients diagnosed as SLE according toSLICC 2012Classification Criteria[13] :
- Patients presented with typical lupus presentation:
- age of onset (20-50)
- common initial manifestations as constitutional manifestations,arthritis, mucocutaneousmanifestationslike malar rash, photosensitivity and hair falling.
- patients with ANA positive.
- Patients presented with atypical lupus presentation:
Show all 19Show fewer
- any clinical presentation not belonging to classic common SLE onset features, including but not limited to:
- Neuropsychiatric onset: seizure, psychosis, aseptic meningitis, transverse myelitis
- Cardiopulmonary onset: pulmonary hypertension, acute pneumonitis, myocarditis, pulmonary hemorrhage
- Gastrointestinal onset: mesenteric vasculitis, intestinal pseudo obstruction, pancreatitis
- Hematologic severe onset: isolated severe thrombocytopenia, autoimmune hemolytic anemia, thrombotic microangiopathy
- Dermatologic atypical onset: bullous lupus, panniculitis, vasculitic ulcers
- Myositis
- Fever of unknown origin (FUO) as sole initial presentation
- Thrombotic events
- Generalized lymphadenopathy.
- Patients with dominant organ affection.
- patients with late onset SLE.
- patients with ANA negative SLE. C.Patients who can provide informed consent.
Who cannot join
- Patients whose initial symptoms are clearly attributable to infection, sepsis or another non-SLE condition.
- Patients with chronic pre-existing diseases that may mimic or obscure the initial SLE presentation (e.g. primary epilepsy, primary pulmonary hypertension, chronic liver or GI disease).
- Patients in whom onset features cannot be reliably classified as typical or atypical due to mixed or unclear presentation.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasmine Fatah Mohamed, MD contact
Ahmed Mohamed Mahrous, professor contact
Egypt1 site
Sohag university hospitals,sohag ,sohag
Sohag
Magdy M Amin, professor, 01117533387, portal@med.sohag.edu.eg
About this study
Official title: Atypical Lupus Presentations and Their Prognostic Implications
Atypical presentations of SLE including unusual initial symptoms, predominant organ involvement, late-onset disease and ANA-negative remain poorly characterized. These forms are often associated with delayed diagnosis and potentially worse clinical outcomes. Most existing studies focus on isolated rare manifestations rather than analyzing atypical SLE as a cohesive category. Understanding these differences is crucial and this study aims to compare atypical and typical SLE presentations to clarify variations in prognosis, treatment requirements and subsequent organ involvement.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| systemic lupus erythematosus patients with typical presentations | Not described | |
| Systemic lupus erythematosus patients with atypical presentations | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity measured by SLEDAI-2K score
SLEDAI-2K score will be calculated for each participant. Data will be reported as mean ± SD and compared between patients with typical and atypical SLE presentations
Measured: Baseline (0 month), 6 months, 12 months
Organ damage accrual measured by SDI score
Systemic Lupus International Collaborating Clinics Damage Index (SDI) will be assessed to evaluate irreversible organ damage. Data will be reported as mean ± SD and compared between patients with typical and atypical SLE presentations
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Feb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Abdelfattah Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350772
- Sponsor's protocol ID
- Soh-Med--25-12-7MD
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atypical Lupus Presentations and Their Prognostic Implications
- ClinicalTrials.gov ID
- NCT07350772
- Acronym / sponsor ID
- Soh-Med--25-12-7MD
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
Atypical presentations of SLE including unusual initial symptoms, predominant organ involvement, late-onset disease and ANA-negative remain poorly characterized. These forms are often associated with delayed diagnosis and potentially worse clinical outcomes. Most existing studies focus on isolated rare manifestations rather than analyzing atypical SLE as a cohesive category. Understanding these differences is crucial and this study aims to compare atypical and typical SLE presentations to clarify variations in prognosis, treatment requirements and subsequent organ involvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic lupus erythematosus patients with typical presentations | – | – |
| Systemic lupus erythematosus patients with atypical presentations | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 400 patients diagnosed according to SLICC classification criteria as systemic lupus erythematosus[13] including 3oo patients with typical common SLE presentation and 100 patients with atypical presentation as rare manifestations,ANA negative lupus, late onset lupus.Patients will be collected from Rheumatology outpatient clinic - Sohag University Hospital.
Key inclusion criteria (19 listed)
- Patients presented with typical lupus presentation:
- age of onset (20-50)
- common initial manifestations as constitutional manifestations,arthritis, mucocutaneousmanifestationslike malar rash, photosensitivity and hair falling.
- patients with ANA positive.
- Patients presented with atypical lupus presentation:
Key exclusion criteria (4 listed)
- Patients whose initial symptoms are clearly attributable to infection, sepsis or another non-SLE condition.
- Patients with chronic pre-existing diseases that may mimic or obscure the initial SLE presentation (e.g. primary epilepsy, primary pulmonary hypertension, chronic liver or GI disease).
- Patients in whom onset features cannot be reliably classified as typical or atypical due to mixed or unclear presentation.
- -
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
Disease activity measured by SLEDAI-2K score
Time frame: Baseline (0 month), 6 months, 12 months
SLEDAI-2K score will be calculated for each participant. Data will be reported as mean ± SD and compared between patients with typical and atypical SLE presentations
Organ damage accrual measured by SDI score
Time frame: 6 months, 12 months
Systemic Lupus International Collaborating Clinics Damage Index (SDI) will be assessed to evaluate irreversible organ damage. Data will be reported as mean ± SD and compared between patients with typical and atypical SLE presentations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Systemic Lupus Erythematosus (SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
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.
Yasmine Fatah Mohamed, MD contact
Ahmed Mohamed Mahrous, professor contact
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 Systemic Lupus Erythematosus (SLE), 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 19 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Fatah Mohamed, MD (01032071095 ext. 01106191664, yasmine_abdelfattah_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity measured by SLEDAI-2K score (time frame: Baseline (0 month), 6 months, 12 months). The study lists 2 primary outcomes in all. 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 20 Jan 2026.