Systemic Lupus Erythematosus
Conditions
Keywords
subcutaneous Belimumab, Individual Patient Compassionate Use, SLE, GSK1550188
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.
Interventions
DRUGSC belimumab 200 mg
Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion 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.
Countries
United States
Outcome results
None listed