Trial of Belimumab in Early Lupus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
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 look at clinical effects as well as effects on the immune system.
Eligibility criteria
Qualifiers
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
Disqualifiers
Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.
Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.
Active renal or nervous system disease or disease activity fulfilling BILAG A criteria
Use of high dose steroids (>0.5 mg/kg/ day) within the 4 weeks prior to screening
Trial design
Treatments tested in this trial
- Belimumab
- Belimumab/Placebo
- Placebo
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Northwell Health
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov