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A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

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Trial Profile

A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Belimumab (Primary) ; Pneumococcal vaccine; Tetanus vaccine
  • Indications Systemic lupus erythematosus
  • Focus Pharmacodynamics
  • Sponsors Human Genome Sciences

Most Recent Events

  • 31 Mar 2016 According to ClinicalTrials.gov reocord, the protocol has been amended to assess the efficacy of belimumab on immune response to pneumococcal vaccine only (and not on tetanus toxoid). Accordingly the purpose, endpoints and the treatment table has been amended.
  • 19 Jan 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 26 Mar 2015 Planned End Date changed from 1 May 2014 to 1 Sep 2015, as reported by ClinicalTrials.gov.

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