Actively Recruiting
Trial of Belimumab in Early Lupus
Led by Northwell Health · Updated on 2024-02-14
30
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Belimumab in Early Lupus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of SLE according to current ACR classification criteria
- SLE diagnosis date within 2 years of screening
- Positive ANA test with a titer of 80 or higher
- Positive anti-ds DNA antibody test
- Mild to moderate disease activity defined by SLEDAI-2K score of 4 or less
- Stable corticosteroid dose of 30 mg/day or less for at least 4 weeks before screening
- Stable methotrexate dose for 4 weeks if used
- Concurrent treatment with hydroxychloroquine unless unable to tolerate
- Able and willing to provide written informed consent and follow study requirements
- Negative serum pregnancy test for women who can become pregnant
- Men and women of reproductive potential must agree to use effective birth control during treatment and for 16 weeks after finishing
You will not qualify if you...
- Previous use of disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine
- Previous use of biologic therapies including rituximab, belimumab, or other investigational SLE agents
- Active renal or nervous system disease meeting BILAG A criteria
- Use of high dose steroids over 0.5 mg/kg/day within 4 weeks before screening
- Expected need for disease modifying drug treatment within the first 52 weeks of the study
- Hemoglobin below 8.0 gm/dL
- Platelets below 50,000/mm
- Absolute neutrophil count below 1.0 x 10^3/mm
- Elevated liver enzymes (AST or ALT) over 2.5 times the upper normal limit unless due to primary disease
- Creatinine clearance 25 ml/min or less per 1.73 m2
- Positive hepatitis B or C tests
- History of positive HIV test
- Participation in another investigational drug study within 4 weeks or 5 half-lives of that drug
- Receipt of live vaccine within 30 days before baseline or during treatment
- History of severe allergic reactions to contrast agents, human or murine proteins, or monoclonal antibodies
- Current treatment for chronic infections like tuberculosis or herpes viruses
- Hospitalization for infection within 60 days before study start
- Use of intravenous or intramuscular antibiotics within 60 days before study start
- History of serious recurrent or chronic infections
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within the past year
- Pregnancy or breastfeeding
- History of psychiatric disorder interfering with study participation
- Significant heart or lung disease including obstructive pulmonary disease
- Any other medical condition or lab abnormality that could increase risk or affect study results
- History of cancer within last 5 years except certain treated skin or cervical cancers
- Serious suicide risk or recent suicidal behavior
- History of primary immunodeficiency
- Significant IgG deficiency below 400 mg/dL
- IgA deficiency below 10 mg/dL
- Other clinically significant abnormal lab values
- Comorbidities requiring corticosteroid therapy with two or more courses in past year
- Inability to comply with study and follow-up procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Feinstein Institute
Manhasset, New York, United States, 11030
Actively Recruiting
Research Team
S
Sanita Kandasami, BS
CONTACT
C
Cynthia Aranow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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