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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00931086 |
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Date of registration:
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30/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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Recruitment status: |
No longer available |
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URL:
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http://clinicaltrials.gov/show/NCT00931086 |
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Study type:
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Expanded Access |
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Study design:
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N/A
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: belimumab
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Secondary ID(s)
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HGS1006-C1089
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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