Trial of Belimumab in Early Lupus

Recruiting Phase 4 Interventional Study
Lupus Erythematosus, Systemic Lupus Erythematosus
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Northwell Health · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 we…
Contacts

Sanita Kandasami, BS

516 562-2401

skandasami@northwell.edu

CONTACT

Cynthia Aranow, MD

516 562-3845

caranow@northwell.edu

CONTACT