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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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12 December 2020 |
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Main ID: |
NCT01597492 |
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Date of registration:
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08/05/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
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Scientific title:
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A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) |
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Date of first enrolment:
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May 31, 2012 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01597492 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Key Inclusion Criteria:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- Autoantibody-positive.
- Have antibodies with titers >1.0 microgram (mcg)/mL to no more than 9 of the 23
serotypes present in the pneumococcal vaccine.
- Have the ability to understand the requirements of the study, provide written informed
consent, and comply with the study protocol procedures.
Key Exclusion Criteria:
- Pregnant or nursing.
- Have received any prior treatment with belimumab.
- Have received a live vaccine within the past 30 days.
- Have received a pneumococcal vaccination with the past 5 years.
- Have a history of severe allergic reaction to a vaccine, contrast agents (such as
those used for x-rays and CT scans), or biological medicines.
- Have required management of an infection or have had infections that keep coming back
within the past 60 days.
- Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of
testing for HB surface antigen (HBsAg) and anti-HB core antibody (anti-HBc):
- Subjects positive for HBsAg are excluded.
- Subjects negative for HBsAg but positive for anti-HBc, regardless of anti-HBs
antibody status, are excluded.
- Hepatitis C: Positive test for Hepatitis C antibody.
- Known human immunodeficiency virus (HIV) infection.
- Have current drug or alcohol abuse or dependence.
- Have a Grade 3/4 immunoglobulin (Ig)G deficiency (IgG level <400 milligrams [mg]/
deciliter [dL]) or IgA deficiency (IgA level <10 mg/dL).
- Subjects who have evidence of serious suicide risk including any history of suicidal
behavior in the last 6 months and/or suicidal ideation with some intent to act in the
last 2 months or who in the investigator's judgment, pose a significant suicide risk.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Biological: Belimumab plus Early Vaccination
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Biological: Belimumab plus Late Vaccination
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Primary Outcome(s)
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Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
[Time Frame: Four weeks after vaccination]
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Secondary ID(s)
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HGS1006-C1117
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115470
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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