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.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00931086
First received: June 30, 2009
Last updated: October 29, 2012
Last verified: October 2012

June 30, 2009
October 29, 2012
April 2009
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00931086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99
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

An expanded access trial of belimumab for named patients who participated in LBRA99.

An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.

Expanded Access
Phase 4
Not Provided
Rheumatoid Arthritis
Drug: belimumab
IV 10mg/kg q28days
Other Names:
  • BENLYSTA™ (belimumab)
  • LymphoStat-B™
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
  2. 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.
  3. 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.
  4. 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 Criteria:

  1. Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
  2. 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.
  3. Are a pregnant female or nursing mother.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931086
HGS1006-C1089
No
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP