CompletedInterventionalPhase 3Last updated Sep 14, 2021

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

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

Overview

ClinicalTrials.gov ID: NCT03707535
Lead Sponsor: CelltrionINDUSTRY
Brief Summary: 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.
Study Type: Interventional

Status

Overall Status: Completed
Start Date: Nov 12, 2018Actual
Primary Completion Date: Mar 16, 2020Actual
Completion Date: Mar 5, 2021Actual

Study Record Dates

First Submitted: Oct 12, 2018
First Submitted that Met QC Criteria: Oct 12, 2018
First Posted: Oct 16, 2018Actual
Last Update Submitted that Met QC Criteria: Sep 13, 2021
Last Update Posted: Sep 14, 2021Actual
Last Verified: Sep 2021

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