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A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus

Trial Profile

A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2023

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At a glance

  • Drugs Belimumab (Primary) ; Rituximab (Primary) ; Methylprednisolone; Mycophenolate mofetil; Prednisolone
  • Indications Systemic lupus erythematosus
  • Focus Proof of concept; Therapeutic Use
  • Acronyms SynBioSe-2
  • Most Recent Events

    • 05 Oct 2023 Planned primary completion date changed from 1 Sep 2023 to 1 Dec 2023.
    • 12 Nov 2022 Trial design published in the Trials.
    • 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
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