A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) - Full Text View

Sponsor:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00071812

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 RA.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: belimumab (LymphoStat-B)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel 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 Rheumatoid Arthritis (RA)

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Immunoglobulins Belimumab Globulin, Immune

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 RA. [ Time Frame: December 2005 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of LymphoStat-B™ in subjects with RA. [ Time Frame: December 2005 ] [ Designated as safety issue: Yes ]

Enrollment:	296
Study Start Date:	December 2003
Study Completion Date:	December 2005

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 RA.

Eligibility

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

Criteria

Primary Inclusion Criteria:

Diagnosis of RA for at least 1 year
Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and TNFα inhibitors (infliximab, etanercept or adalimumab)
Active RA disease of at least moderate disease activity
Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days

Primary Exclusion Criteria:

Received a non-FDA approved investigational agent within the last 28 days
Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
Currently receiving or received within the last 6 months the following: anti-CD20 antibody(rituximab)or cyclophosphamide
Steroid injection into any joint within the last 30 days
History of hypogammaglobulinemia or IgA deficiency
History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
HIV, Hepatitis-B, Hepatitis-C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071812

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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
Boling Clinical Trials
Rancho Cucamonga, California, United States, 91730
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Arthritis Care Center, Inc.
San Jose, California, United States, 95126-1650
Stanford University School of Medicine
Palo Alto, California, United States, 94304
UCDMC
Sacramento, California, United States, 95817-1418
University of Southern California
Los Angeles, California, United States, 90033
Wallace Rheumatic Disease 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
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
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
Rockford Clinic
Rockford, Illinois, United States, 61103
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
United States, Maryland
Center for Rhematology and Bone Research
Wheaton, Maryland, United States, 20902
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, United States, 21502
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, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
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
Arthritis and Osteoporosis Center
Concord, New Hampshire, United States, 03301
Strafford Medical Associates, P.A.
Dover, New Hampshire, United States, 03820
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
North Shore University Hospital
Manhasset, New York, United States, 11030
SUNY-Downstate Medical Center
Brooklyn, New York, United States, 11203
The Center For Rheumatology
Albany, New York, United States, 12206
United States, North Carolina
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7280
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
McBride Clinic
Oklahoma City, Oklahoma, United States, 73101
United States, Pennsylvania
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Research Associates of North Texas
Dallas, Texas, United States, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8884
Arthritis Centers of Texas
Dallas, Texas, United States, 75246
Texas Research Center
Sugar Land, Texas, United States, 77479
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
United States, Utah
Arthritis and Rheumatic Diseases Clinic
Weber, Utah, United States, 84403
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
Evergreen Clinical Reserach
Edmonds, Washington, United States, 98026-8047
Rheumatology Northwest Clinical Trials
Yakima, Washington, United States, 98902
United States, Wisconsin
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
The Medical College of Wisconsin , Inc
Milwaukee, Wisconsin, United States, 53226
Marshfield Medical Research Foundation
Wausau, Wisconsin, United States, 54401
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, United States, 54610

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

No publications provided

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	LBRA01
Study First Received:	October 31, 2003
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00071812 History of Changes
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health

Keywords provided by Human Genome Sciences:

RA

Additional relevant MeSH terms:

Antibodies
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Physiological Effects of Drugs
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009