Back to resultsAn Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Etanercept
Autoinjector
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Subjects are male or female aged 18-55 years at the time of signing the informed consent form.
Exclusion Criteria:
- Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
Sites / Locations
- AI Centrum Medyczne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SB4
Arm Description
SB4 (etanercept) 50 mg/mL
Outcomes
Primary Outcome Measures
The change in Injection site pain score at immediately post injection (within 1 minute)
The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03193957
First Posted
June 19, 2017
Last Updated
October 12, 2017
Sponsor
Samsung Bioepis Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03193957
Brief Title
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Official Title
An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
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
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB4
Arm Type
Experimental
Arm Description
SB4 (etanercept) 50 mg/mL
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Etanercept PFS and Autoinjector
Intervention Type
Device
Intervention Name(s)
Autoinjector
Intervention Description
Autoinjector
Primary Outcome Measure Information:
Title
The change in Injection site pain score at immediately post injection (within 1 minute)
Description
The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale
Time Frame
at Week 1 and Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects are male or female aged 18-55 years at the time of signing the informed consent form.
Exclusion Criteria:
Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
Facility Information:
Facility Name
AI Centrum Medyczne
City
Poznań
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
31372961
Citation
Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.
Results Reference
derived
Learn more about this trial
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
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