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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

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ClinicalTrials.gov Identifier: NCT03707535
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: CT-P13 Biological: Remicade Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CT-P13 Biological: CT-P13
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

Active Comparator: China-approved Remicade Biological: Remicade
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid




Primary Outcome Measures :
  1. Efficacy assessment: DAS28 (CRP) at Week 14 [ Time Frame: 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])



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707535


Contacts
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Contact: MinJi Ma +82328506727 MinJi.Ma@celltrion.com
Contact: PilHyun Nam +82328503496 PilHyun.Nam@celltrion.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Xiaofeng Zeng         
Sponsors and Collaborators
Celltrion

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03707535     History of Changes
Other Study ID Numbers: CT-P13 3.6
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents