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.
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