Status:
COMPLETED
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 rheumatoi...
Detailed 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 m...
Eligibility Criteria
Inclusion
- Key
- The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA) by satisfying at least four of the seven criteria;
- Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 7.5-25 mg, and a stable dose for 28 days prior to treatment (Day 1)
- The patient must have active disease at both screening and baseline, as defined by having both:
- 6 tender/painful joints on motion (out of 68 joints assessed); and; 6 swollen joints (out of 66 joints assessed); CRP ≥ 7 mg/L, or ESR ≥28 mm/h
- Key
Exclusion
- Pregnant or lactating females.
- History of any other autoimmune rheumatic disease.
- Patients who have previously received CTLA4-Ig therapy for any reason.
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04038970
Start Date
November 8 2019
End Date
July 28 2022
Last Update
March 1 2023
Active Locations (1)
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1
Pingxiang people's hospital
Pingxiang, Pingxiang, China, 337055