Compassionate Use for Subcutaneous (SC) Belimumab

Status No longer available

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03125486
Study type	Expanded Access
Source	GlaxoSmithKline
Contact
Status	No longer available
Phase	N/A

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03843125` - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)	Phase 3
Recruiting	`NCT05698173` - Systemic Lupus Erythematosus and Accelerated Aging	N/A
Active, not recruiting	`NCT01649765` - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	Phase 2
Recruiting	`NCT05704153` - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)	N/A
Completed	`NCT05048238` - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus	Phase 1
Recruiting	`NCT06056778` - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed	`NCT04358302` - Individual Patient Exposure and Response in Pediatric Lupus	N/A
Completed	`NCT03802578` - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients	N/A
Completed	`NCT02554019` - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT04835883` - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients	Phase 2
Terminated	`NCT02665364` - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00278538` - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00069342` - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed	`NCT03252587` - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus	Phase 2
Terminated	`NCT02066311` - Nelfinavir in Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT01892748` - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	N/A
Terminated	`NCT01689025` - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	Phase 1
Unknown status	`NCT01712529` - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients	N/A
Completed	`NCT01475149` - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)	N/A
Completed	`NCT00962832` - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Phase 2