Compassionate Use for Subcutaneous (SC) Belimumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Interventions

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SC belimumab 200 mg

Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No