NCT00001372

Study of Systemic Lupus Erythematosus

Recruiting now Last updated 6 April 2026

What this trial tests

trial in Systemic Lupus Erythematosus in 2,000 participants. Currently enrolling.

Timeline

10 February 1994

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	10 February 1994
Sites	1 location across United States

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Who can join

Adults 3 to 120, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neutrophil subsets and their gene signature associate with vascular inflammation and coronary atherosclerosis in lupus.
   Carlucci PM, Purmalek MM, Dey AK, Temesgen-Oyelakin Y, et al · · 2018 · cited 140× · PMID 29669944 · DOI 10.1172/jci.insight.99276
2. The percentage of FoxP3+Helios+ Treg cells correlates positively with disease activity in systemic lupus erythematosus.
   Golding A, Hasni S, Illei G, Shevach EM. · · 2013 · cited 82× · PMID 23925905 · DOI 10.1002/art.38119
3. Boosting NAD+ blunts TLR4-induced type I IFN in control and systemic lupus erythematosus monocytes.
   Wu J, Singh K, Lin A, Meadows AM, et al · · 2022 · cited 59× · PMID 35025762 · DOI 10.1172/jci139828
4. Genetically programmed alternative splicing of NEMO mediates an autoinflammatory disease phenotype.
   Lee Y, Wessel AW, Xu J, Reinke JG, et al · · 2022 · cited 32× · PMID 35289316 · DOI 10.1172/jci128808
5. ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.
   Pfiffner PB, Oh J, Miller TA, Mandl KD. · · 2014 · cited 10× · PMID 25334031 · DOI 10.1371/journal.pone.0111055
6. Yoga for systemic lupus erythematosus (SLE): Clinician experiences and qualitative perspectives from students and yoga instructors living with SLE.
   Middleton KR, Haaz Moonaz S, Hasni SA, Magaña López M, et al · · 2018 · cited 6× · PMID 30477826 · DOI 10.1016/j.ctim.2018.09.001