To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Has a diagnosis of rheumatoid arthritis
Has active disease as defined in DAS28 Criteria

Exclusion criteria

Has a history of tuberculosis (TB) or a current diagnosis of TB
Has previously received a biological agent
Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
Pregnant or lactating

Treatment and study plan

CT-P13

Biological

3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

Remicade

Biological

3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

Primary outcomes

Efficacy assessment: DAS28 (CRP) at Week 14

Time frame: Week 14

Clinical response according to the change from baseline in disease activity as measured by the Disease Activity Score using 28 joint counts (DAS28) (C-reactive protein[CRP])

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Oct 16, 2018
Registry last updated: Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed