ClinicalTrials.gg
RecruitingNCT00001372Updated Oct 29, 2026

Study of Systemic Lupus Erythematosus

An observational study in Systemic Lupus Erythematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Recruiting at 1 site in United States. Open to participants aged 3 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational

From the registry’s dates

  • Started Feb 1994; still recruiting 32 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
3 Years to 120 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) — 4 open to participants now, 4 under way, none of them phase 3. Lupus Erythematosus, Systemic · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Started
1994
the only one that year
Observational
6 of 15
3 open now
Registered
1st of 15
by date

Among the 15 studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), this one is the only one that started in 1994, is one of 6 observational ones, and was the 1st registered.

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

Browse Lupus Erythematosus, Systemic studies →

Open to participants now

4 of the 15 studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.

This study: 3 Years to 120 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), or all of them as a file.
02

Study summary

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

Patients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include:

  1. Electrocardiogram
  2. 24-hour urine collection
  3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.
  4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.
  5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm.
  6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is removed, using a sharp cookie cutter-type instrument.
  7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions.
  8. Genetic studies-Collection of a blood sample for gene testing.

Patients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll.

Participating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing.

Read the detailed description

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.

03

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Longitudinal Study
  • Natural History
  • Lupus Nephritis
  • Lupus
  • Systemic Lupus
  • SLE
04

Who can participate

Ages eligible
3 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

subjects with systemic lupus erythematosus (SLE) and their relatives

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans and Hispanics. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient s permission to contact his/her relatives.

  • SLE or suspected SLE established by ACR/EULAR or ACR criteria
  • Ability to give
  • Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
  • Ability of the patient or minor relative s parents to give informed consent
  • Affected individuals age >= 3 years with no upper age limit
  • Healthy Volunteers (non-related) age >=18 with no upper age limit
  • Healthy Volunteers (first- and second-degree relatives) age >=3 with no upper age limit
  • Vascular studies adults only age >=18 with no upper age limit

Exclusion criteria

EXCLUSION CRITERIA:

  • Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of in the blood, active , 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
  • Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)
  • 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)
  • Unwilling to participate in research studies or to provide research samples or data
  • Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for

EXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:

  • Subjects with a to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:

    • Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI
    • Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI
    • Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI
    • Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI
    • Ocular foreign body (e.g. metal shavings)
    • Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI
    • Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
  • Subjects with renal excretory dysfunction, estimated \< 60 mL/min/1.73m\^2 using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.
  • Pregnant or lactating women will be excluded from vascular studies.
  • Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.
  • Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
  • Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • 1

    Longitudinal cohort study with affected SLE patients

  • 2

    Patient relatives

  • 3

    Unrelated healthy volunteers

06

What researchers measure

Primary outcomes

  1. Natural History of SLE

    Natural History of SLE

    Time frame: 12/31/2050

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • Lee Y, Wessel AW, Xu J, Reinke JG, Lee E, Kim SM, Hsu AP, Zilberman-Rudenko J, Cao S, Enos C, Brooks SR, Deng Z, Lin B, de Jesus AA, Hupalo DN, Piotto DG, Terreri MT, Dimitriades VR, Dalgard CL, Holland SM, Goldbach-Mansky R, Siegel RM, Hanson EP. Genetically programmed alternative splicing of NEMO mediates an autoinflammatory disease phenotype. J Clin Invest. 2022 Mar 15;132(6):e128808. doi: 10.1172/JCI128808. PubMed 35289316 ↗
  • Wu J, Singh K, Lin A, Meadows AM, Wu K, Shing V, Bley M, Hassanzadeh S, Huffstutler RD, Schmidt MS, Blanco LP, Tian R, Brenner C, Pirooznia M, Kaplan MJ, Sack MN. Boosting NAD+ blunts TLR4-induced type I IFN in control and systemic lupus erythematosus monocytes. J Clin Invest. 2022 Mar 1;132(5):e139828. doi: 10.1172/JCI139828. PubMed 35025762 ↗
  • Carlucci PM, Purmalek MM, Dey AK, Temesgen-Oyelakin Y, Sakhardande S, Joshi AA, Lerman JB, Fike A, Davis M, Chung JH, Playford MP, Naqi M, Mistry P, Gutierrez-Cruz G, Dell'Orso S, Naz F, Salahuddin T, Natarajan B, Manna Z, Tsai WL, Gupta S, Grayson P, Teague H, Chen MY, Sun HW, Hasni S, Mehta NN, Kaplan MJ. Neutrophil subsets and their gene signature associate with vascular inflammation and coronary atherosclerosis in lupus. JCI Insight. 2018 Apr 19;3(8):e99276. doi: 10.1172/jci.insight.99276. eCollection 2018 Apr 19. PubMed 29669944 ↗
  • Pfiffner PB, Oh J, Miller TA, Mandl KD. ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. PLoS One. 2014 Oct 21;9(10):e111055. doi: 10.1371/journal.pone.0111055. eCollection 2014. PubMed 25334031 ↗

Individual participant data

Plan to share: No — We plan to share aggregate data for analysis. Any IPD shared will be deidentified and coded.

09

Timeline

3 registry updates since Sep 25, 2026

Started Feb 1994 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Feb 10, 1994
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and description
3 updates, last Oct 29, 2026
Show all 3 updates
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 9, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001372
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Feb 10, 1994
Last update
Oct 29, 2026

Study contacts

Sarfaraz A Hasni, M.D.
Contact
hasnisa@mail.nih.gov
(301) 451-1599
Sarfaraz A Hasni, M.D.
principal investigator · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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