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A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB5 40mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab PFS and Pen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale | Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6. | Difference of injection site pain score (Week 6 - Week 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS. | at Week 2 and at Week 6 |
| Subject Preference of SC Delivery Administration of SB5 Using Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.
Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB indicated by a positive QuantiFERON® Gold test result.
Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.
Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
Have any of the following conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia | Gdynia | Poland | ||||
| Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30561229 | Derived | Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis. Curr Med Res Opin. 2019 Mar;35(3):497-502. doi: 10.1080/03007995.2018.1560211. Epub 2019 Jan 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB5 40mg | Adalimumab PFS and Pen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| at Week 6 |
| Warsaw |
| Poland |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | SB5 40mg | Adalimumab PFS and Pen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale | Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6. | Posted | Number | 97.5% Confidence Interval | Difference (scores on a scale) | Difference of injection site pain score (Week 6 - Week 2) |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS. | Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'. | Posted | Count of Participants | Participants | at Week 2 and at Week 6 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Overall number of participants analyzed means number of subjects with available assessment results | Posted | Number | number of responders | at Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB5 40mg | Adalimumab PFS and Pen | 0 | 49 | 0 | 49 | 4 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd. | sbregistry@samsung.com |
| 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 |
|---|---|
| C058388 | penclomedine |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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