Pilot Trial of Belimumab in Early Lupus
Northwell Health
Summary
This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.
Description
This protocol proposes that early treatment of Systemic Lupus Erythematous (SLE) may prevent tissue damage and may even lead to long-term remission of disease. This concept is supported by reports of SLE-associated autoimmunity that are detected serologically many years prior to any constitutional symptoms or specific tissue inflammation and immune dysregulation precedes the development of clinically apparent SLE. Belimumab (Benlysta) is an FDA approved medication and is a monoclonal antibody directed against B cell-activating factor (BAFF)/ B Lymphocyte Stimulator (BLyS). B cells maturing in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of SLE per current ACR classification criteria * Date of SLE diagnosis within 2 years of screening * ANA positive (with a titer ≥ 80) * anti-ds DNA antibody positive * Mild to moderate disease activity define by a SLEDAI-2K ≥4 * Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day. * If on methotrexate, dose must be stable for 4 weeks * Concomitant treatment with hydroxychloroquine unless documented inability to tolerate * Able and willing to give written informed consent and comply with the requirements of the study protocol * Negative serum…
Interventions
- BiologicalBelimumab
Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years
- BiologicalBelimumab/Placebo
Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.
- OtherPlacebo
Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years
Location
- Feinstein InstituteManhasset, New York