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

August 1, 2013 updated by: Human Genome Sciences Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
449

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • University of Alabama at Birmingham
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis Research
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • LaJolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
      • Rancho Cucamonga, California, United States, 91730
        • Boling Clinical Trials
      • Sacramento, California, United States, 95817-1418
        • UCDMC
      • San Jose, California, United States, 95126-1650
        • Arthritis Care Center, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Arthritis Associates & Osteoporosis Center of Colorado Springs
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Idaho
      • Boise, Idaho, United States, 83704
        • Radiant Research Boise
      • Idaho Falls, Idaho, United States, 83404
        • Institute of Arthritis and Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical School
      • Chicago, Illinois, United States, 60612
        • Rheumatology Associates
    • Indiana
      • Munster, Indiana, United States, 46321
        • Medical Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Center for Better Bone and Joint Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Cumberland, Maryland, United States, 21502
        • The Osteoporosis and Arthritis Clinical Trial Center
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts--New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0358
        • The University of Michigan Health System
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Arthritis Center of Nebraska
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Arthritis and Osteoporosis Center
      • Dover, New Hampshire, United States, 03820
        • Strafford Medical Associates, P.A.
    • New York
      • Albany, New York, United States, 12206
        • The Center for Rheumatology
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY-Downstate Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Rochester, New York, United States, 14618
        • Aair Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7280
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28210
        • Arthritis Clinic and Carolina Bone and Joint
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Dayton, Ohio, United States, 45402
        • Stat Research Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, United States, 73103
        • Bone and Joint Hospital
      • Tulsa, Oklahoma, United States, 74114
        • Oklahoma Center For Arthritis Therapy & Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Medicine & ASPH
      • Willow Grove, Pennsylvania, United States, 19090
        • Rheumatic Disease Associates
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Associates of North Texas
      • Dallas, Texas, United States, 75390-8884
        • UT Southwestern Medical Center at Dallas
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center
    • Utah
      • Ogden, Utah, United States, 84044
        • Arthritis and Rheumatic Disease Clinic
      • Sandy, Utah, United States, 84070
        • Physicians Research Options, LC
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.
    • Washington
      • Edmonds, Washington, United States, 98026-8047
        • Edmonds Rheumatology Associates
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest Rheumatology
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54610
        • Gundersen Clinic, Ltd.
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin , Inc
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Medical Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo plus SOC
Drug: Placebo
Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Experimental: Belimumab 1 mg/kg plus SOC
Drug: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Other Names:
  • LymphoStat-B®
  • BENLYSTA®
Experimental: Belimumab 4 mg/kg plus SOC
Drug: Belimumab 4 mg/kg
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Other Names:
  • LymphoStat-B®
  • BENLYSTA®
Experimental: Belimumab 10 mg/kg plus SOC
Drug: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
Other Names:
  • LymphoStat-B®
  • BENLYSTA®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
Time Frame: 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.
Baseline, 24 weeks
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
Time Frame: 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).
0 to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
Time Frame: 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
Baseline, 52 weeks
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
Time Frame: 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.
Baseline and every 4 to 8 weeks through Week 52
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
Time Frame: 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.
Baseline, 52 weeks
Area Under the Curve (AUC) of BILAG Score at Week 52
Time Frame: 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.
Baseline and every 4 to 8 weeks through Week 52
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
Time Frame: 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.
0 to 52 weeks
Percentage of Patients With a Reduction in Prednisone Dose
Time Frame: 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.
Baseline, weeks 40 to 52

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events (AE) Overview
Time Frame: Up to 84 weeks
Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).
Up to 84 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Genome Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LBSL02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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