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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707535
• Other study ID #: CT-P13 3.6
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2018
• Est. completion date: March 5, 2021

Study information

• Verified date: September 2021
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 5, 2021
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 a) inhibitor

• Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products

• Pregnant or lactating

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• CT-P13
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
• Remicade
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy assessment: DAS28 (CRP) at 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])	Week 14