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

NCT04038970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

KN019, 5mg/kg

Solution, intravenous, 5 mg/kg

BIOLOGICAL

KN019, 10 mg/kg

Solution, intravenous, 10 mg/kg

BIOLOGICAL

Placebo

Solution, intravenous, Placebo

COMBINATION_PRODUCT

Methotrexate

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

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2022-07-28
Completion
2022-07-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038970 on ClinicalTrials.gov