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A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB4 | Experimental | SB4 (etanercept) 50 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept PFS and Autoinjector |
| |
| Autoinjector |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AI Centrum Medyczne | Poznan | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31372961 | Derived | 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. |
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| Device |
Autoinjector |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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