Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

• Status: No longer available
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies; Belimumab

Criteria

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.