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

NCT07350772 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25-12-7MD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months, 12 months

Study Arms (2)

systemic lupus erythematosus patients with typical presentations

Systemic lupus erythematosus patients with atypical presentations

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospitals,sohag ,sohag

Sohag, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yasmine Fatah Mohamed, MD

CONTACT

01032071095; yasmine_abdelfattah_post@med.sohag.edu.eg

Ahmed Mohamed Mahrous, professor

CONTACT

01009323356

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 20, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

EG (1)