Back to resultsA Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CT-P47 AI (tocilizumab)
CT-P47 PFS (tocilizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-P47 SC (tocilizumab)
Arm Description
CT-P47 (tocilizumab) by subcutaneous (SC) injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05725434
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 6, 2023 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-P47 SC (tocilizumab)
Arm Type
Experimental
Arm Description
CT-P47 (tocilizumab) by subcutaneous (SC) injection
Intervention Type
Biological
Intervention Name(s)
CT-P47 AI (tocilizumab)
Intervention Description
CT-P47 (162 mg/0.9 mL) by subcutaneous (SC) injection via autoinjector (AI) at Week 0 and Week 2
Intervention Type
Biological
Intervention Name(s)
CT-P47 PFS (tocilizumab)
Intervention Description
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
Primary Outcome Measure Information:
Title
The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2.
Description
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.
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YeonJu Kim
Phone
+82-32-850-5000
Email
yeonju.kim2@celltrion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klimiuk Piotr, MD, PhD
Organizational Affiliation
INTER CLINIC Piotr Adrian Klimiuk
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
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