Phase II/III Results of a Trial of Anti-Tumor Necrosis Factor Multivalent NANOBODY Compound Ozoralizumab in Patients With Rheumatoid Arthritis.

ABSTRACT:

Objective

To assess the efficacy and safety of subcutaneous administration of 30 mg or 80 mg of ozoralizumab plus methotrexate (MTX) in patients with rheumatoid arthritis (RA) whose disease remained active despite MTX therapy.

Methods

In this multicenter, double-blind, parallel-group, placebo-controlled phase II/III trial, 381 patients were randomized to receive placebo, ozoralizumab 30 mg, or ozoralizumab 80 mg, plus MTX subcutaneously injected every 4 weeks for 24 weeks. The primary end points were the response rates based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 16 and change in the Sharp/van der Heijde score (ΔSHS) from baseline to week 24.

Results

The proportion of patients with an ACR20 response at week 16 was significantl

SUBMITTER: Takeuchi T 

PROVIDER: S-EPMC9828347 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature