Status:
NO_LONGER_AVAILABLE
Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99
Lead Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
An expanded access trial of belimumab for named patients who participated in LBRA99.
Detailed Description
An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.
Eligibility Criteria
Inclusion
- Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
- Over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception.
- Over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception.
- Have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits.
Exclusion
- Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
- Had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to RA (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk.
- Are a pregnant female or nursing mother.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
EXPANDED_ACCESS
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00931086
Start Date
April 1 2009
End Date
December 1 2011
Last Update
October 31 2012
Active Locations (1)
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1
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806