Trial Profile
A multi-centre, randomised, parallel group, placebo-controlled double-blind trial to evaluate the safety, efficacy and pharmacokinetics of belimumab, a human monoclonal anti-BLyS antibody, plus standard therapy in paediatric patients with Systemic Lupus Erythematosus (SLE)
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 12 Dec 2022
Price :
$35
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At a glance
- Drugs Belimumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Therapeutic Use
- Acronyms PLUTO
- Sponsors GlaxoSmithKline; GSK
- 14 Nov 2022 Results of a meta-analysis by pooling individual patient MBC flow cytometry data from 1245 patients with SLE from from four randomised clinical trials (NCT00071487, NCT00410384, NCT01632241 and NCT01649765) and extensive B-cell subset phenotyping was performed prospectively by employing high-sensitivity flow cytometry (NCT03312907 and NCT03747159) presented at the ACR Convergence 2022.
- 27 Jul 2022 According to a GlaxoSmithKline media release, the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy. The approval extends the current indication in the US to include both lupus and active LN for the intravenous formulation in the pediatric patient population.
- 04 Jun 2022 Results of a meta-analysis by pooling individual patient MBC flow cytometry data from 1245 patients with SLE from from four randomised clinical trials (NCT00071487, NCT00410384, NCT01632241 and NCT01649765) and extensive B-cell subset phenotyping was performed prospectively by employing high-sensitivity flow cytometry (NCT03312907 and NCT03747159) presented at the 23rd Annual Congress of the European League Against Rheumatism