Study Stopped
Sponsor decision - not related to safety
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
1 other identifier
interventional
155
2 countries
48
Brief Summary
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Jan 2005
Longer than P75 for phase_2 rheumatoid-arthritis
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 29, 2011
CompletedAugust 7, 2013
August 1, 2013
4.8 years
December 20, 2007
April 7, 2011
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Up to 5 years
Secondary Outcomes (1)
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
up to 5 Years
Study Arms (1)
Belimumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have completed the LBRA01 trial.
- Have achieved at least an ACR20 response at the end of LBRA01.
You may not qualify if:
- Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.
- 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.
- 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).
- new DMARDs.
- new DMARD plus high dose prednisone \>10 mg/day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Arthritis Research
Paradise Valley, Arizona, 85253, United States
Arthritis Health
Scottsdale, Arizona, 85260, United States
The University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University of Southern CA
Los Angeles, California, 90033, United States
Wallace Rheumatic Disease Center
Los Angeles, California, 90048, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
Arthritis Care Center, Inc.
San Jose, California, 95126, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80910, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Radiant Research Boise
Boise, Idaho, 83704, United States
Rheumatology Associates
Chicago, Illinois, 60612, United States
Medical Specialists
Munster, Indiana, 46321, United States
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, 40202, United States
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, 21502, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68506, United States
Strafford Medical Associates, P.A.
Dover, New Hampshire, 03820, United States
The Center for Rheumatology
Albany, New York, 12206, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Wake Forest Unviersity School of Medicine
Winston-Salem, North Carolina, 27599-7280, United States
Bone and Joint Hospital - Research Department
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Medical Reseach Foundation
Oklahoma City, Oklahoma, 74114, United States
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, 74114, United States
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, 15261, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8884, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Texas Research Center
Sugar Land, Texas, 77479, United States
IPC Clinical Research
Ogden, Utah, 84403, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, 22205, United States
Seattle Arthritis Clinic
Seattle, Washington, 98133, United States
Arthritis Northwest Rheumatology
Spokane, Washington, 99204, United States
Rheumatology Northwest Clinical Trials
Yakima, Washington, 98902, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Gundersen Clinic, LTD
La Crosse, Wisconsin, 54610, United States
Marshfield Medical Research Foundation
Wausau, Wisconsin, 54401, United States
NZOZ Centrum Medyczne
Bialystok, Poland
Wojewodzki Zespol Reumatologiczny
Sopot, Poland
Instytut Reumaologii
Warsaw, Poland
Instytut Reumatologii
Warsaw, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 31, 2007
Study Start
January 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
August 7, 2013
Results First Posted
June 29, 2011
Record last verified: 2013-08