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A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies

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Trial Profile

A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 19 Jan 2022

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At a glance

  • Drugs Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus First in man; Pharmacokinetics
  • Acronyms ASSIST-RA
  • Sponsors HEXAL; Novartis Healthcare; Sandoz

    • Most Recent Events

    • 23 Jul 2020 Results assessing efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis published in the Rheumatology
    • 02 May 2018 According to a Sandoz media release, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.
    • 14 Nov 2017 Results from this trial were presented at the American College of Rheumatology (ACR) Annual Meeting according to a Sandoz media release.

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