Rheumatoid Arthritis
Conditions
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 rheumatoid arthritis and inadequate response to methotrexate.
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 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate.
Interventions
BIOLOGICALKN019, 5mg/kg
Solution, intravenous, 5 mg/kg
BIOLOGICALKN019, 10 mg/kg
Solution, intravenous, 10 mg/kg
BIOLOGICALPlacebo
Solution, intravenous, Placebo
COMBINATION_PRODUCTMethotrexate
Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* Pregnant or lactating females. * History of any other autoimmune rheumatic disease. * Patients who have previously received CTLA4-Ig therapy for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169 | At 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. |
Countries
China
Outcome results
None listed