Back to resultsTo Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CT-P13
Remicade
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-P13
China-approved Remicade
Arm Description
Outcomes
Primary Outcome Measures
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])
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03707535
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P13
Arm Type
Experimental
Arm Title
China-approved Remicade
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
CT-P13
Intervention Description
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Intervention Type
Biological
Intervention Name(s)
Remicade
Intervention Description
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Primary Outcome Measure Information:
Title
Efficacy assessment: DAS28 (CRP) at Week 14
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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