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

Sponsor:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00071487

Purpose

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease.

Condition	Intervention	Phase
Lupus Erythematosus, Systemic	Drug: belimumab Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Belimumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate the safety and tolerability of LymphoStat-B™ in subjects with SLE. [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of LymphoStat-B™ in subjects with SLE. [ Time Frame: Februrary 2006 ] [ Designated as safety issue: Yes ]

Enrollment:	449
Study Start Date:	October 2003
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Drug: belimumab 1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
2: Experimental 4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Drug: belimumab 4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
3: Experimental 10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Drug: belimumab 10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
4: Placebo Comparator Placebo Comparator	Drug: Placebo IV on Days 0, 14, 28, and every 28 days through 52 weeks

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, 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 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 IgA deficiency
HIV, Hepatitis B, Hepatitis C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071487

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Locations

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

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

No publications provided by Human Genome Sciences

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51.

Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78.

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	LBSL02
Study First Received:	October 24, 2003
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00071487 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

SLE

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on November 22, 2009