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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
Solution, intravenous, 5 mg/kg
Solution, intravenous, 10 mg/kg
Solution, intravenous, Placebo
Pingxiang people's hospital
Pingxiang, Pingxiang, China
Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169
The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.
Time frame: At Day 169
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition