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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2022-07-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KN019 5mg/kg

Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Group Type EXPERIMENTAL

KN019, 5mg/kg

Intervention Type BIOLOGICAL

Solution, intravenous, 5 mg/kg

Methotrexate

Intervention Type COMBINATION_PRODUCT

Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

KN019 10mg/kg

Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Group Type EXPERIMENTAL

KN019, 10 mg/kg

Intervention Type BIOLOGICAL

Solution, intravenous, 10 mg/kg

Methotrexate

Intervention Type COMBINATION_PRODUCT

Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

Placebo

Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Solution, intravenous, Placebo

Methotrexate

Intervention Type COMBINATION_PRODUCT

Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

Interventions

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KN019, 5mg/kg

Solution, intravenous, 5 mg/kg

Intervention Type BIOLOGICAL

KN019, 10 mg/kg

Solution, intravenous, 10 mg/kg

Intervention Type BIOLOGICAL

Placebo

Solution, intravenous, Placebo

Intervention Type BIOLOGICAL

Methotrexate

Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Exclusion Criteria

* Pregnant or lactating females.
* History of any other autoimmune rheumatic disease.
* Patients who have previously received CTLA4-Ig therapy for any reason.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No