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
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).
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.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →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:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
By country, each count listing its studies:
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.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 2 · Phase 3 1
First in 1994; this study’s year is marked. 1 started in 1994.
This study's planned enrollment of 2,000 is above the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 23 across the 9 interventional studies, 81 across the 6 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
2 of the studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05567198National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires | 2027-05-31 |
| NCT05440422National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD | 2027-08-01 |
Among the 15 studies in Lupus Erythematosus, Systemic by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), from their registry updates:
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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:
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.
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.
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.
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.
EXCLUSION CRITERIA:
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:
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.
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.
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.
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.
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 (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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Longitudinal cohort study with affected SLE patients
Patient relatives
Unrelated healthy volunteers
Natural History of SLE
Natural History of SLE
Time frame: 12/31/2050
Plan to share: No — We plan to share aggregate data for analysis. Any IPD shared will be deidentified and coded.
Started Feb 1994 (actual).
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic →
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