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

Sponsor
Human Genome Sciences Inc., a GSK Company (Industry)
Overall Status
No longer available
CT.gov ID
NCT00931086
Collaborator
GlaxoSmithKline (Industry)
1
Location
32
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

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 :
Apr 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Dec 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Human Genome Sciences Inc., a GSK Company
    ClinicalTrials.gov Identifier:
    NCT00931086
    Other Study ID Numbers:
    • HGS1006-C1089
    First Posted:
    Jul 2, 2009
    Last Update Posted:
    Oct 31, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Human Genome Sciences Inc., a GSK Company
    Rheumatoid Arthritis
    RA
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Belimumab

    Study Results

    No Results Posted as of Oct 31, 2012