A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: CT-P17 SC AI (adalimumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04171414

2019-000660-25 (EudraCT Number)

CT-P17 3.2

Details and patient eligibility

About

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 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 evaluate usability of subcutaneous auto-injector of CT-P17 in patients with moderate to severe rheumatoid arthritis.

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient aged 18 to 70 years, inclusive.
• Patient must be able and willing to self-administer subcutaneous (SC) injections via auto injector (AI).

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

"CT-P17 SC AI (adalimumab)"

Experimental group

Description:

CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)

Treatment:

Biological: CT-P17 SC AI (adalimumab)