A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
NCT05725434 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-02-16
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
Interventions
- BIOLOGICAL
-
CT-P47 AI (tocilizumab)
CT-P47 (162 mg/0.9 mL) by subcutaneous (SC) injection via autoinjector (AI) at Week 0 and Week 2
- BIOLOGICAL
-
CT-P47 PFS (tocilizumab)
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Klimiuk Piotr, MD, PhD · INTER CLINIC Piotr Adrian Klimiuk
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-06
- Primary Completion
- 2023-04-01
- Completion
- 2023-07-31
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