Rheumatoid Arthritis Clinical Trial
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
| Verified date | July 2017 |
| Source | Samsung Bioepis Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | September 25, 2017 |
| Est. primary completion date | August 3, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | AI Centrum Medyczne | Poznan |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Bioepis Co., Ltd. |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | at Week 1 and Week 3 |
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