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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: |
NCT02486939 |
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Date of registration:
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26/06/2015 |
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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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A Long Term Safety Extension Study (CHS-0214-05)
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Scientific title:
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An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05) |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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359 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02486939 |
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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 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Barbara Finck, 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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Coherus Biosciences, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an
ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at
least a PASI-50
Exclusion Criteria:
- None
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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Plaque Psoriasis
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Rheumatoid Arthritis
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Intervention(s)
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Drug: CHS-0214
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Primary Outcome(s)
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Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA
[Time Frame: 48 Weeks]
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In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.
[Time Frame: Week 0,4,12,24,36,48]
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Secondary Outcome(s)
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DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.
[Time Frame: 48 Weeks]
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Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.
[Time Frame: 108 Weeks]
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Secondary ID(s)
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CHS-0214-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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