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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: CT-P13; Biological: Remicade

• Registration Number: NCT03707535
• Lead Sponsor: Celltrion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Study Start: 2018-11-12
• Primary Completion: 2020-03-16
• Study Completion: 2021-03-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13	CT-P13	-
China-approved Remicade	Remicade	-

Primary Outcome Measures

Name	Time	Method
Efficacy assessment: DAS28 (CRP) at Week 14	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\[CRP\])

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China