Back to resultsCompassionate Use for Subcutaneous (SC) Belimumab
Primary Purpose
Systemic Lupus Erythematosus
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
SC belimumab 200 mg
Sponsored by
About this trial
This is an expanded access trial for Systemic Lupus Erythematosus focused on measuring subcutaneous Belimumab, Individual Patient Compassionate Use, SLE, GSK1550188
Eligibility Criteria
This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab).
Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use:
- The illness being treated is life threatening or seriously debilitating.
- There are no satisfactory alternative treatments (confirmed by the HCP).
- There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03125486
Brief Title
Compassionate Use for Subcutaneous (SC) Belimumab
Official Title
Compassionate Use for Subcutaneous (SC) Belimumab
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
subcutaneous Belimumab, Individual Patient Compassionate Use, SLE, GSK1550188
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SC belimumab 200 mg
Intervention Description
Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab).
Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use:
The illness being treated is life threatening or seriously debilitating.
There are no satisfactory alternative treatments (confirmed by the HCP).
There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use for Subcutaneous (SC) Belimumab
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