Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99
Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
First received: June 30, 2009
Last updated: October 29, 2012
Last verified: October 2012
An expanded access trial of belimumab for named patients who participated in LBRA99.
What is Expanded Access?
||An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
IV 10mg/kg q28days
- BENLYSTA™ (belimumab)
An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931086
|Rheumatology Associates of Central Florida
|Orlando, Florida, United States, 32806 |
Human Genome Sciences Inc., a GSK Company
||GSK Clinical Trials
No publications provided
||GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 30, 2009
||October 29, 2012
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs