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
Price :
$35
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At a glance
- Drugs Rituximab (Primary)
- Indications Rheumatoid arthritis
- Focus First in man; Pharmacokinetics; Registrational
- Sponsors Amgen
- 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.