NIAID Clinical Trials Seek People With Lupus
In people with systemic lupus erythematosus (SLE or lupus), the immune system attacks healthy cells and tissues by mistake and often causes damage to joints, skin, blood vessels, and organs. Anyone can get lupus, but women are most at risk. Lupus is also more common in African American, Hispanic, Asian, and Native American women. The cause of lupus is not known.
Although researchers have made considerable progress in understanding autoimmune diseases, much remains to be learned. Research teams across the United States are currently seeking people with lupus to volunteer for NIAID-sponsored clinical studies.
Clinical Research Studies of Systemic Lupus Erythematosus (SLE or Lupus)
Lupus is an autoimmune disease characterized by inflammation of different tissues of the body. The most common type of lupus is systemic lupus erythematosus (SLE), which affects different parts of the body including internal organs. The causes of SLE are unknown but are believed to be linked to genetic, environmental, and hormonal factors. Women of childbearing ages are at greatest risk of developing SLE.
The NIAID role in lupus research includes supporting clinical trials that are conducted across the United States. The following are select studies sponsored by NIAID. The links lead to full descriptions, eligibility criteria, and contact information.
Autologous Polyclonal Tregs for Lupus (NCT02428309)
Regulatory T cells (Tregs) are a specialized subset of T cells that function to control the immune response. The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of three different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus.
Regulatory T cells (Tregs) are a specialized subset of T cells that function to control the immune response. The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of three different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus.
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (NCT01946880)
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
Rituximab and Belimumab for Lupus Nephritis (NCT02260934)
Lupus nephritis is a severe form of SLE with active disease in the kidneys. When SLE affects the kidneys, stronger immune suppressing treatment is usually needed. In this experimental study, researchers will try to find out if treatment of lupus nephritis with a specific drug combination is safe and can block the immune system attacks.
Lupus nephritis is a severe form of SLE with active disease in the kidneys. When SLE affects the kidneys, stronger immune suppressing treatment is usually needed. In this experimental study, researchers will try to find out if treatment of lupus nephritis with a specific drug combination is safe and can block the immune system attacks.


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