Compassionate Use for Subcutaneous (SC) Belimumab

Systemic Lupus Erythematosus Clinical Trial

Official title:

Compassionate Use for Subcutaneous (SC) Belimumab

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03125486
• Other study ID #: 207616
• Status: No longer available
• Phase: N/A
• First received: April 18, 2017
• Last updated: February 26, 2018

Study information

• Verified date: February 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• SC belimumab 200 mg
Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States,