EUCTR2011-005667-25-ESActive, not recruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)0 sites4,018 target enrollmentStarted: December 21, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 4,018
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- •- Active SLE disease.
- •- Autoantibody-positive.
- •- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
Exclusion Criteria
- •- Pregnant or nursing.
- •- Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
- •- Have received a live vaccine within the past 30 days.
- •- Have severe active lupus kidney disease.
- •- Have severe active central nervous system (CNS) lupus.
- •- Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Investigators
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