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

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

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Sep 2017

At a glance

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

    • 12 Sep 2017 According to a Sandoz media release, The US FDA accepted Biologics License Application (BLA) under the 351(k) pathway for a proposed biosimilar to the reference medicine, rituximab (Rituxan).This submission is based on data from ASSIST-RA and ASSIST-FL studies.
    • 19 Jun 2017 According to a Sandoz media release, The European Commission (EC) has approved Rixathon(biosimilar rituximab) to treat the same indications as the reference product (MabThera).This approval is based on results from biosimilar development program that included this and ASSIST-FL trials.
    • 21 Apr 2017 According to a Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted positive opinion recommending approval of biosimilar rituximab to treat the same indications as the reference product (MabThera). The recommendation was based on results from biosimilar development program that included this and ASSIST-FL trials.
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