Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597622
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2012-05-10
Brief Title:
BEL114333 a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus SLE in Northeast Asia and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
BEL114333 a Multicenter Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus SLE Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 referred to as C1115 Study in Japan the option of continuing treatment with belimumab 10 mgkg intravenously every 4 weeks for those randomized to belimumab or the option to begin treatment with belimumab for those randomized to placebo as an add-on to their standard of care SLE therapy
Detailed Description:
This is a multicentre continuation study of belimumab plus standard of care SOC in SLE subjects who completed the Phase III BEL113750 protocol in Northeast Asia or who completed the open-label extension of the HGS1006-C1115 protocol in Japan This study provides subjects who complete the BEL113750 study the option of continuing treatment with belimumab 10 mgkg intravenously every 4 weeks for those randomized to belimumab or the option to begin treatment with belimumab for those randomized to placebo as an add-on to their SOC SLE therapy Subjects participating in this continuation protocol will continue to be monitored for safety and efficacy as measured by the SLE responder index Subjects who complete 48 weeks of treatment on the BEL113750 study and who meet inclusionexclusion criteria and provide informed consent will be given the option to enter the continuation study All subjects will receive belimumab 10 mgkg IV infused over 1 hour every 4 weeks Subjects recruited into this study will continue to receive treatment with belimumab until such time as belimumab becomes commercially available in a subjects country of participation or the subject elects to participate in another belimumab continuation study for SLE or until either the subjects physician withdraws the subject from the study or upon the decision by the sponsor to discontinue further development of belimumab for SLE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None