A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Placebo
+ Belimumab 1 mg/kg
+ Belimumab 4 mg/kg
Autoimmune Diseases+1
+ Connective Tissue Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.449 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Primary Inclusion Criteria * Clinical diagnosis of SLE * "Active" SLE disease * On a stable SLE treatment regimen * History of measurable autoantibodies Primary Exclusion Criteria * Received a non-FDA approved investigational agent within last 28 days * Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days * Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 90 days * Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days * History of renal transplant * History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days * History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency * Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 62 locations
Arizona Arthritis Research
Paradise Valley, United StatesUniversity of Arizona
Tucson, United StatesScripps Clinic
LaJolla, United States