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

Celltrion270 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

270

Conditions

Rheumatoid Arthritis

Interventions

CT-P13BIOLOGICAL

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

RemicadeBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

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\[CRP\])

Time frame: Week 14

Data from ClinicalTrials.gov

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