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)

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)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Therapeutic Use
  • Acronyms PLUTO
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 02 Nov 2017 Planned End Date changed from 31 Jan 2028 to 16 Feb 2028.
    • 02 Nov 2017 Planned primary completion date changed from 15 Jan 2018 to 31 Jan 2018.
    • 27 Jul 2017 Planned number of patients changed from 100 to 70.
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