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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01101100 |
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Date of registration:
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01/04/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
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Scientific title:
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A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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181 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01101100 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. 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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Australia
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Canada
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Denmark
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France
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United States
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Contacts
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Name:
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MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amgen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject was randomized into Study 20090062 and completed the week 16 evaluation.
Exclusion Criteria:
- Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was
considered possibly related to IP.
- Subject experienced an adverse event in Study 20090062 that, in the opinion of the
investigator, could cause extension of treatment to be detrimental to the subject.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: AMG 827
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Primary Outcome(s)
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Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
[Time Frame: 264 weeks]
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Percent Change in Psoriasis Area and Severity Index (PASI)
[Time Frame: 264 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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