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

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‐contro...

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Published in:Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2022-11, Vol.74 (11), p.1776-1785
Main Authors: Takeuchi, Tsutomu, Kawanishi, Masafumi, Nakanishi, Megumi, Yamasaki, Hironori, Tanaka, Yoshiya
Format: Article
Language:English
Subjects:
Antibodies
Antibodies, Monoclonal - therapeutic use
Antirheumatic Agents - therapeutic use
Arthritis
Arthritis, Rheumatoid - chemically induced
Arthritis, Rheumatoid - drug therapy
Double-Blind Method
Drug Therapy, Combination
Full Length
Humans
Methotrexate
Nanobodies
Necrosis
Patients
Placebos
Rheumatoid Arthritis
Rheumatology
Safety
Signs and symptoms
Treatment Outcome
Tumor necrosis factor
Tumor Necrosis Factor-alpha
Tumor necrosis factor-TNF
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Summary: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 significantly higher (P 
ISSN:2326-5191
2326-5205
DOI:10.1002/art.42273