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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Remicade; Biological: CT-P13

Study type: Interventional

Funder types: Industry

Identifiers

NCT03707535

CT-P13 3.6

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 2 patient groups

CT-P13

Experimental group

Treatment:

Biological: CT-P13

China-approved Remicade

Active Comparator group

Treatment:

Biological: Remicade