It is an Observational Study That Compare Prognosis of Typical and Atypical Systemic Lupus Erythematosus Presentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus (SLE). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Atypical Lupus Presentations and Their Prognostic Implications
Overview
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.
Primary outcome measures
- Disease activity measured by SLEDAI-2K score [Time frame: Baseline (0 month), 6 months, 12 months]
- Organ damage accrual measured by SDI score [Time frame: 6 months, 12 months]
Eligibility criteria
Inclusion criteria
Patients diagnosed as SLE according toSLICC 2012Classification Criteria\[13\] :
A. 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.
B. Patients presented with atypical lupus presentation:
- 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.
Exclusion criteria
- 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.
Exclusion criteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Sohag university hospitals,sohag ,sohag — Sohag
Identifiers
NCT: NCT07350772 · Soh-Med--25-12-7MD