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Studies

Interventional Not yet recruiting Phase 3

NCT05725434 on ClinicalTrials.gov

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

Official title: A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis

  • Sponsor: Celltrion (South Korea)
  • Enrollment: 30 (Estimated)
  • Study start: 2023-02-06 (Estimated)
  • Primary completion: 2023-04-01 (Estimated)
  • Study completion: 2023-07-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

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

Primary Outcome Measures

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

Study Officials

  • Klimiuk Piotr, MD, PhD (Principal Investigator) — INTER CLINIC Piotr Adrian Klimiuk