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A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Aug 2022

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At a glance

  • Drugs Siltuximab (Primary)
  • Indications Giant lymph node hyperplasia
  • Focus Registrational; Therapeutic Use
  • Sponsors Centocor; Janssen Research & Development
  • Most Recent Events

    • 14 Dec 2021 Results assessing the impact of baseline CRP levels on response to anti-IL-6 therapy, SIL, patients were divided into low and high CRP groups based on a baseline CRP level threshold of 40 mg/l, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
    • 02 Dec 2021 According to a BeiGene media release,based on results from this study, the China National Medical Products Administration (NMPA) has approved SYLVANT (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD).
    • 11 Feb 2020 According to an EUSA Pharma media release, the National Comprehensive Cancer Network has updated their Clinical Practice Guidelines in Oncology for B-Cell Lymphomas to include SYLVANT (siltuximab) as a preferred primary treatment for patients with human immunodeficiency virus-negative and human herpesvirus 8-negative multicentric Castleman disease (MCD).The NCCN based their recommendation on data from this phase 2 study and a retrospective analysis performed by the CDCN on the same data.
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