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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707535

Enrollment

270

Registered

2018-10-16

Start date

2018-11-12

Completion date

2021-03-05

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

BIOLOGICALCT-P13

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

BIOLOGICALRemicade

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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\[CRP\])

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026