It is an Observational Study That Compare Prognosis of Typical and Atypical Systemic Lupus Erythematosus Presentation

Atypical Lupus Presentations and Their Prognostic Implications

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07350772

Enrollment

400

Registered

2026-01-20

Start date

2026-02-20

Completion date

2027-08-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE)

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients diagnosed as SLE according toSLICC 2012Classification Criteria\[13\] : A. Patients presented with typical lupus presentation: 1. age of onset (20-50) 2. common initial manifestations as constitutional manifestations,arthritis, mucocutaneousmanifestationslike malar rash, photosensitivity and hair falling. 3. patients with ANA positive. B. Patients presented with atypical lupus presentation: 1. 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. 2. Patients with dominant organ affection. 3. patients with late onset SLE. 4. patients with ANA negative SLE. C.Patients who can provide informed consent.

Exclusion criteria

1. Patients whose initial symptoms are clearly attributable to infection, sepsis or another non-SLE condition. 2. 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). 3. Patients in whom onset features cannot be reliably classified as typical or atypical due to mixed or unclear presentation.

Design outcomes

Primary

Measure	Time frame	Description
Disease activity measured by SLEDAI-2K score	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	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

Countries

Egypt

Contacts

CONTACTYasmine Fatah Mohamed, MD

yasmine_abdelfattah_post@med.sohag.edu.eg01032071095

CONTACTAhmed Mohamed Mahrous, professor

01009323356

Outcome results