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

NCT03707535 — Phase 3, Completed, 270 participants, Celltrion

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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

Registry	NCT03707535
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	270 (Actual)
Sponsor	Celltrion (Industry)
Conditions	Rheumatoid Arthritis
Interventions	CT-P13, Remicade (Biological)
Dates	start 2018-11-12, primary completion 2020-03-16, completion 2021-03-05, first posted 2018-10-16, last updated 2021-09-14
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
CT-P13	Experimental	Biological: CT-P13
China-approved Remicade	Active comparator	Biological: Remicade

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

+Outcome measures

Primary outcomes

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\[CRP\])

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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)

Facility	City	Country	Status
Peking Union Medical College Hospital	Beijing	China

My Notes

Public

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