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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: CT-P17 SC; Biological: Humira SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03789292

CT-P17 3.1

2018-001690-25 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 648 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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648 participants in 2 patient groups

CT-P17 Subcutaneous(SC) (adalimumab)

Experimental group

Description:

CT-P17 SC (adalimumab)

Treatment:

Biological: CT-P17 SC

Humira SC (adalimumab)

Active Comparator group

Description:

Humira SC (adalimumab)

Treatment:

Biological: CT-P17 SC

Biological: Humira SC