A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis

Celltrion Healthcare

Status and phase

Not yet enrolling

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: CT-P47 PFS (tocilizumab)

Biological: CT-P47 AI (tocilizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05725434

CT-P47 3.2

Details and patient eligibility

About

This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe active rheumatoid arthritis.

Full description

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is male or female aged 18 to 70 years old, both inclusive.
Patient must be able and willing to self-administer SC injections.
Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria (Aletaha et al., 2010) for at least 24 weeks prior to the first administration of the study drug (Day 1).

Exclusion criteria

Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
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.