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Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Clinical Trial Summary

The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of KN019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.

Clinical Trial Description

This study is designed to provide efficacy data in support of the proposed claims of reducing signs and symptoms, improvement in physical function, and 1 year safety data for KN019 dosed at 5 and 10 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04038970
Study type Interventional
Source Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date November 8, 2019
Completion date July 28, 2022
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