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

Sponsor
Celltrion
Study ID
NCT05725434
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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 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

Study Details

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.

Key Dates

Start date
Feb 6, 2023
Status verified
Feb 2023
Primary completion
Apr 1, 2023
Completion
Jul 31, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CT-P47 SC (tocilizumab)
    CT-P47 (tocilizumab) by subcutaneous (SC) injection

Primary Outcome Measure

The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2. [ Time Frame: Week 2 ]

Central Contacts

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