A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
NCT ID: NCT00583557
Last Updated: 2013-08-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
155 participants
INTERVENTIONAL
2005-01-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Belimumab
belimumab
IV 10mg/kg Q28 days
Interventions
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belimumab
IV 10mg/kg Q28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have achieved at least an ACR20 response at the end of LBRA01.
Exclusion Criteria
2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.
3. Used prohibited medications during their participation in LBRA01. These medications include the following:
* Other investigational agents.
* Biologic response modifiers
* Cyclophosphamide.
* Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
* 2 new DMARDs.
* 1 new DMARD plus high dose prednisone \>10 mg/day.
18 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis Research
Paradise Valley, Arizona, United States
Arthritis Health
Scottsdale, Arizona, United States
The University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of Southern CA
Los Angeles, California, United States
Wallace Rheumatic Disease Center
Los Angeles, California, United States
Boling Clinical Trials
Rancho Cucamonga, California, United States
Arthritis Care Center, Inc.
San Jose, California, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Radiant Research Boise
Boise, Idaho, United States
Rheumatology Associates
Chicago, Illinois, United States
Medical Specialists
Munster, Indiana, United States
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, United States
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, United States
Strafford Medical Associates, P.A.
Dover, New Hampshire, United States
The Center for Rheumatology
Albany, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, United States
Wake Forest Unviersity School of Medicine
Winston-Salem, North Carolina, United States
Bone and Joint Hospital - Research Department
Oklahoma City, Oklahoma, United States
Oklahoma Medical Reseach Foundation
Oklahoma City, Oklahoma, United States
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, United States
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States
Arthritis Centers of Texas
Dallas, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
IPC Clinical Research
Ogden, Utah, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States
Seattle Arthritis Clinic
Seattle, Washington, United States
Arthritis Northwest Rheumatology
Spokane, Washington, United States
Rheumatology Northwest Clinical Trials
Yakima, Washington, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Gundersen Clinic, LTD
La Crosse, Wisconsin, United States
Marshfield Medical Research Foundation
Wausau, Wisconsin, United States
NZOZ Centrum Medyczne
Bialystok, , Poland
Wojewodzki Zespol Reumatologiczny
Sopot, , Poland
Instytut Reumaologii
Warsaw, , Poland
Instytut Reumatologii
Warsaw, , Poland
Countries
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Related Links
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ClinicalTrials.gov Posting for Parent Protocol LBRA01
Other Identifiers
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LBRA99
Identifier Type: -
Identifier Source: org_study_id