Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789292
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: CT-P17 SC Biological: Humira SC Phase 3

Detailed Description:
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: CT-P17 Subcutaneous(SC) (adalimumab)
CT-P17 SC (adalimumab)
Biological: CT-P17 SC
Subcutaneous injection of Adalimumab 40mg every two weeks

Active Comparator: Humira SC (adalimumab)
Humira SC (adalimumab)
Biological: CT-P17 SC
Subcutaneous injection of Adalimumab 40mg every two weeks

Biological: Humira SC
Subcutaneous injection of Adalimumab 40mg every two weeks




Primary Outcome Measures :
  1. Clinical response according to the ACR definition of a 20% improvement (ACR20) [ Time Frame: Week 24 ]
    Proportion of patients achieving clinical response (according to the ACR20 criteria)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 is male or female aged 18 to 75 years old, both inclusive.
  • Patient has had a diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .

Exclusion Criteria:

  • Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
  • Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

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): NCT03789292


Locations
Layout table for location information
Bulgaria
National Multiprofile Transport Hospital Tsar Boris III
Sofia, Bulgaria
Sponsors and Collaborators
Celltrion

Layout table for additonal information
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03789292     History of Changes
Other Study ID Numbers: CT-P17 3.1
2018-001690-25 ( EudraCT Number )
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents