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Trial record 2 of 17 for:    CT-P13

A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA

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ClinicalTrials.gov Identifier: NCT03147248
Recruitment Status : Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13 SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Infliximab Phase 3

Detailed Description:
A new subcutaneous infliximab formulation is being developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase I/III Study randomized, open-label, multicenter, parallel-group study is designed to Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active RA
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : July 16, 2018
Estimated Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: CT-P13 IV
CT-P13 IV (Infliximab)
Biological: Infliximab
Experimental: CT-P13 SC
CT-P13 IV (Infliximab)
Biological: Infliximab



Primary Outcome Measures :
  1. To demonstrate that CT-P13 SC is noninferior to CT-P13 IV at Week 22, in terms of efficacy, as determined by clinical response according to change from baseline in disease activity measured by Disease Activity Score using 28 joint counts [ Time Frame: Week 22 ]
    Primary Efficacy endpoint is the mean change from baseline in disease activity measured by DAS28 (CRP) at Week 22



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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:

  • Patient has a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 6 months

Exclusion Criteria:

  • Patient who has previously received a biological agent for the treatment of RA and/or a TNFα inhibitor for the treatment of other disease
  • Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product

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): NCT03147248


Locations
Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
Study Chair: SuEun Song Celltrion

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03147248     History of Changes
Other Study ID Numbers: CT-P13 3.5 (SC)
2016-002125-11 ( EudraCT Number )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents