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A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis.

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Trial Profile

A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus First in man; Pharmacokinetics; Registrational
  • Sponsors Amgen

    • Most Recent Events

    • 17 Dec 2020 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx) for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA).
    • 19 Dec 2019 According to an Allergan, Amgen media release, the company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan(rituximab).The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies.
    • 22 Aug 2019 According to Amgen media release, this study is intended to support regulatory submissions for ABP 798.
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