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

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ClinicalTrials.gov Identifier: NCT00931086
Recruitment Status : No longer available
First Posted : July 2, 2009
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: belimumab

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

Study Type : Expanded Access
Official Title: 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 : April 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Belimumab
U.S. FDA Resources


Intervention Details:
    Drug: belimumab
    IV 10mg/kg q28days
    Other Names:
    • BENLYSTA™ (belimumab)
    • LymphoStat-B™

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931086


Locations
United States, Florida
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT00931086     History of Changes
Other Study ID Numbers: HGS1006-C1089
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Rheumatoid Arthritis
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Belimumab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents