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Evaluation of Systemic Lupus Erythematosus (SLE) Pathogenesis and Natural History Through Patient and Relative Examinations and Specimen Collection

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Study Aim

This study aims to observe and understand the natural progression of Systemic Lupus Erythematosus (SLE) in patients, by examining both the patients and their relatives, and collecting specimens for further analysis.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+11

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 3 to 120 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 1994
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ContactSarfaraz A Hasni, M.D.More contacts
Last updated: September 16, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 10, 1994

Actual date on which the first participant was enrolled.

This research protocol will evaluate subjects with systemic lupus erythematosus (SLE) and their relatives to study the pathogenesis and natural history of the disease and the mechanisms leading to enhanced organ damage. Patients will be evaluated by a history and physical examination and routine laboratory studies will be obtained as needed to assess disease activity or complications of the disease and to monitor for drug-related toxicities. Blood, skin or urine specimens may be requested for research purposes, including genetic studies. In addition, a subset of these patients will undergo several tests to understand the pathogenic changes affecting their blood vessels. Patients who are eligible for other research protocols will be offered the opportunity to participate in these studies by signed informed consent. Any medical care recommended or provided to the patient will be consistent with routine standards of practice and provided in consultation with the patient s referring physician. Blood and urine samples and cardiovascular testing will also be collected or applied to from healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates.

NCT00001372
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ContactSarfaraz A Hasni, M.D.More contacts
Last updated: September 16, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesConnective Tissue DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesNephritisUrologic DiseasesSkin and Connective Tissue DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicLupus Nephritis

Criteria

9 inclusion criteria required to participate
Ability of the patient or minor relative s parents to give informed consent

Ability to give informed consent

Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)

Affected individuals age >= 3 years with no upper age limit

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12 exclusion criteria prevent from participating
Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)

Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for

Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies

Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center