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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Belimumab
Biological/VaccineSubjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years
Belimumab/Placebo
Biological/VaccineSubjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.
Placebo
Other interventionSubjects in this arm will receive weekly subcutaneous injections of placebo for 2 years
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: BelimumabActive comparator 1 intervention
Group B: Belimumab/PlaceboExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of anergic autoreactive naïve B cells
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
Time frame
Assessment at year 1Secondary outcomes
1
Frequency of anergic autoreactive naïve B cells
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
Time frame
Assessment at year 22
Frequency of autoreactivity in transitional B cells
The frequency of autoreactive B cells in the transitional B cell subset will be identified by flow cytometry.
Time frame
Year 13
Frequency of autoreactivity in transitional B cells
The frequency of autoreactive B cells in the transitional B cell subset will be identified by flow cytometry.
Time frame
Year 24
Time to reconstitution of B cell subsets in subjects in belimumab/placebo arm randomized to receive placebo after 1 year of belimumab therapy
B cell numbers decrease following belimumab; the time for B cell reconstituion will be determined
Time frame
Year 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwell Health
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov