Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

Phase 2

Completed

Conditions: Lupus Erythematosus, Systemic

Interventions: Drug: Belimumab 4 mg/kg
Drug: Belimumab 10 mg/kg
Drug: Placebo
Drug: Belimumab 1 mg/kg

Registration Number: NCT00071487

Lead Sponsor: Human Genome Sciences Inc.

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 449

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Belimumab 4 mg/kg plus SOC	Belimumab 4 mg/kg	-
Belimumab 10 mg/kg plus SOC	Belimumab 10 mg/kg	-
Placebo plus SOC	Placebo	-
Belimumab 1 mg/kg plus SOC	Belimumab 1 mg/kg	-

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.	Baseline, 24 weeks	SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)	0 to 52 weeks	The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in SELENA SLEDAI Score at Week 52	Baseline, 52 weeks	SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52	Baseline and every 4 to 8 weeks through Week 52	SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52	Baseline, 52 weeks	The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Area Under the Curve (AUC) of BILAG Score at Week 52	Baseline and every 4 to 8 weeks through Week 52	The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks	0 to 52 weeks	SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Percentage of Patients With a Reduction in Prednisone Dose	Baseline, weeks 40 to 52	Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.

Trial Locations

Locations (61): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Arizona Arthritis Research
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Paradise Valley, Arizona, United States
University of Arizona
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Tucson, Arizona, United States
Scripps Clinic
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LaJolla, California, United States
University of Southern California
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Los Angeles, California, United States
Cedars-Sinai Medical Center
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Los Angeles, California, United States
Stanford University School of Medicine
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Palo Alto, California, United States
Boling Clinical Trials
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Rancho Cucamonga, California, United States
UCDMC
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Sacramento, California, United States
Arthritis Care Center, Inc.
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San Jose, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States