Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03193957 |
Date of registration:
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19/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
Date of first enrolment:
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May 15, 2017 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03193957 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Poland
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Device: Autoinjector
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Drug: Etanercept
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Primary Outcome(s)
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The change in Injection site pain score at immediately post injection (within 1 minute)
[Time Frame: at Week 1 and Week 3]
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Secondary ID(s)
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SB4-G21-RA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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