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Compassionate Use for Subcutaneous (SC) Belimumab

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ClinicalTrials.gov Identifier: NCT03125486
Expanded Access Status : No longer available
First Posted : April 24, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Drug: SC belimumab 200 mg

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Compassionate Use for Subcutaneous (SC) Belimumab

Resource links provided by the National Library of Medicine

Drug Information available for: Belimumab

Interventions
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Intervention Details:
  • Drug: SC belimumab 200 mg
    Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125486


Locations
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United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03125486    
Other Study ID Numbers: 207616
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by GlaxoSmithKline:
subcutaneous Belimumab
Individual Patient Compassionate Use
SLE
GSK1550188
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs