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

NCT05725434 | Unknown Phase 3 DMC

• 1 other identifier: CT-P47 3.2
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2.

  The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence, pain and skin reactions, ease of use and satisfaction with self-injection.

  Week 2

Study Arms (1)

CT-P47 SC (tocilizumab)

EXPERIMENTAL

CT-P47 (tocilizumab) by subcutaneous (SC) injection

Biological: CT-P47 AI (tocilizumab); Biological: CT-P47 PFS (tocilizumab)

Interventions

CT-P47 AI (tocilizumab) BIOLOGICAL

CT-P47 (162 mg/0.9 mL) by subcutaneous (SC) injection via autoinjector (AI) at Week 0 and Week 2

CT-P47 SC (tocilizumab)

CT-P47 PFS (tocilizumab) BIOLOGICAL

CT-P47 (162 mg/0.9 mL) by SC injection via pre-filled syringe from Week 4 every other week or weekly (based on the clinical response by investigator's discretion) up to Week 10

CT-P47 SC (tocilizumab)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Related Publications (1)

• Burmester G, Klimiuk PA, Trefler J, Jaworski J, Kim S, Bae Y, Jeon D, Lee H, Jang J, Hwang C, Lee H, Smolen JS. Usability, efficacy, and safety of candidate tocilizumab biosimilar CT-P47 self-administration via auto-injector and pre-filled syringe in patients with rheumatoid arthritis: a single-arm, open-label, phase 3 study. Expert Rev Clin Immunol. 2025 Apr;21(4):521-529. doi: 10.1080/1744666X.2025.2451215. Epub 2025 Jan 15.

  PMID: 39803727 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Klimiuk Piotr, MD, PhD

  INTER CLINIC Piotr Adrian Klimiuk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YeonJu Kim

CONTACT

+82-32-850-5000; yeonju.kim2@celltrion.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 6, 2023
• Primary Completion: April 1, 2023
• Study Completion: July 31, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02