Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07350772

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Mahrous, professor

CONTACT

01009323356

Yasmine Fatah Mohamed, MD

CONTACT

[email protected]

01032071095 ext. 01106191664

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Atypical Lupus Presentations and Their Prognostic Implications

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.