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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

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
United States, Wisconsin | |
GSK Investigational Site | |
Milwaukee, Wisconsin, United States, 53215 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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 |
subcutaneous Belimumab Individual Patient Compassionate Use SLE GSK1550188 |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Belimumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |