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)
Phase of Trial: Phase IV
Latest Information Update: 16 Nov 2016
At a glance
- Drugs Belimumab (Primary) ; Pneumococcal vaccine; Tetanus vaccine
- Indications Pneumococcal infections; Systemic lupus erythematosus; Tetanus
- Focus Pharmacodynamics
- Sponsors Human Genome Sciences
- 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.