Ongoing Studies

Lupus Registry and Biobank
The purpose of this study is to create a longitudinal electronic registry of patients diagnosed with systemic lupus erythematosus (SLE). This registry will serve as a comprehensive overview of the disease course of the patients. People participating in the registry may be individually contacted about trials and additional research studies. The information that is collected includes name, date of birth, address, phone number, clinical information from medical record and from questionnaires completed by physicians and patients. Any leftover unneeded blood, urine, and diagnostic specimens will be stored and used in lupus research. Patients may be asked to donate additional blood, urine, or other diagnostic specimens. The choice whether to participate or not is up to the patient.

The Cognitive Behavioral Therapy in Childhood-Onset Systemic Lupus Erythematosus
The purpose of this study is to test a cognitive behavioral therapy tailored to meet needs of teens and young adults with lupus. Participants will meet with a psychologist for six one-on-one sessions to learn skills to manage and cope with their symptoms. Their primary caregiver/support will also be involved. During sessions, participants will learn skills that will help them manage their symptoms related to lupus, including fatigue, pain, and mood symptoms.

Open-Label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults with Lupus
The goal of the study is to assess the safety, tolerability, effectiveness and pharmacology of tofacitinib in young adults with lupus. Patients with skin lesions or hair loss from lupus will be treated with stable standard of care background medications for lupus and the study medication, tofacitinib, will be added to treat associated active skin lesions due to lupus, based on the observed improvement of inflammatory rashes in previous trials of tofacitinib in various populations. All study participant receive tofacitinib free of chargeand will receive payment for their time.

Research Study to Learn More about What Causes Lupus and to Find New Therapeutics
This is a research study to determine the cause of lupus, to improve understanding of the disease, and discover new therapeutics. The study specifically seeks to find the genes and viral causes that are involved in lupus development. Laboratory experiments using blood are done to learn why people with lupus react differently from healthy peopleor those with other rheumatic diseases. Studying lupus at the molecular level may advance diagnostic and treatment approaches for lupus.

Falk Medical Research Trust Catalyst Award: Harnessing natural killer cells to treat autoimmune disease
This innovative study aims to harness a type of blood cell present in your immune system called natural killer (NK) cells to reduce the impact of other types of immune cells in lupus (that is, to eliminate T cells and suppress B-cell production of autoantibodies). This research explores a new treatment approach to lupus that is hoped to improve the rate of disease remission.

Renal Activity Index of Lupus Nephritis
The objectives of this study are to identify and validate urinary biomarkers and to develop standardized operating procedures in diagnosis and follow-up of patients with lupus nephritis. The principal hypothesis to be tested is that urinary biomarkers will allow the accurate monitoring of the lupus nephritis activity from a urine test.

Urine S100A4 as a Biomarker of Lupus Nephritis Activity and Podocyte Injury
The objective of this study is to establish urine S100A4 as a novel lupus nephritis (LN) activity biomarker and to further determine how S100A4 may contribute to disease mechanisms in LN. S100A4 levels will be measured in the urine of patients with LN to gauge whether levels decrease with histologic improvement in LN. S100A4 will also be compared to other urinary biomarkers being developed for LN and podocyte-specific markers. We will then examine the urine sediment of LN patients to figure out which cells stain positive for S100A4, thereby identifying the cellular source of S100A4. The goal of this project is to develop a new LN biomarker to better detect active kidney inflammation and improve treatment for children with LN.

Advanced Monitoring in Central Nervous System Lupus
The purpose of this study is to detect neuropsychiatric lupus early by a combination of computer based neurocognitive testing, specialized brain imaging and novel blood testing. Serial testing is done and is expected to improve patient prognosis in the long-term.

The BASE Study
The purpose of this study is to identify barriers to treatment adherence in SLE patients through focus groups of adolescents and young adults. After enrollment, participants will be divided into two focus groups based on age: 13-17 and 18-21 years. The goal of this study is to develop intervention bundles for modifiable barriers with the aim of improving adherence to treatment.

Current Studies, Closed to Enrollment

Validation of Cutaneous Lupus Disease Area and Severity Index (CLASI) and Skindex-29 in Patients in Childhood-Onset Lupus
This is a clinical research study to determine the correlation of skin scoring system (CLASI) and skin specific quality of life questionnaire (Skindex-29) with the severity of skin manifestations in childhood-onset systemic lupus erythematosus.

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)
The objectives of this multicenter study are to evaluate the safety, tolerability, efficacy, and pharmacokinetics of intravenous belimumab, a specific inhibitor of B-lymphocyte stimulator. The study includes three phases: randomized placebo-controlled, long-term open label, and long-term safety follow-up.