Home
Clinical Trials
NCT03789292

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

NCT ID: NCT03789292

Last Updated: 2021-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-P17 Subcutaneous(SC) (adalimumab)

CT-P17 SC (adalimumab)

Group Type EXPERIMENTAL

CT-P17 SC

Intervention Type BIOLOGICAL

Subcutaneous injection of Adalimumab 40mg every two weeks

Humira SC (adalimumab)

Humira SC (adalimumab)

Group Type ACTIVE_COMPARATOR

CT-P17 SC

Intervention Type BIOLOGICAL

Subcutaneous injection of Adalimumab 40mg every two weeks

Humira SC

Intervention Type BIOLOGICAL

Subcutaneous injection of Adalimumab 40mg every two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-P17 SC

Subcutaneous injection of Adalimumab 40mg every two weeks

Intervention Type BIOLOGICAL

Humira SC

Subcutaneous injection of Adalimumab 40mg every two weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 American College of Rheumatology(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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MinJi Ma

Role: STUDY_CHAIR

Celltrion, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Multiprofile Transport Hospital Tsar Boris III

Sofia, , Bulgaria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria

References

Explore related publications, articles, or registry entries linked to this study.

Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.

Reference Type DERIVED

PMID: 34142111 (View on PubMed)

Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7.

Reference Type DERIVED

PMID: 33546755 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-001690-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P17 3.1

Identifier Type: -

Identifier Source: org_study_id