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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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16 December 2017 |
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Main ID: |
NCT01680159 |
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Date of registration:
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28/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
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Scientific title:
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Date of first enrolment:
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July 2012 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01680159 |
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Study type:
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Interventional |
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Study design:
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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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Hideshi Torii, 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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Social Insurance Central General Hospital |
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Name:
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Kazuoki Kondo, 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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Mitsubihsi Tanabe Pharma Corporation |
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Name:
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Hidemi Nakagawa, 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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The Jikei University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have already been diagnosed as having plaque psoriasis, psoriatic
arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
- Patients in whom effect of the treatment was confirmed for a certain period after the
start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased
thereafter.
Exclusion Criteria:
- Patients who have guttate psoriasis.
- Patients who have drug-induced psoriasis
- Patients who have previously used any other biological products than infliximab.
- Patients who have a concomitant diagnosis, or a history within 6 months prior to
provisional enrollment, of serious infections that need hospitalization.
- Patients who have a concomitant diagnosis, or a history within 6 months prior to
provisional enrollment, of opportunistic infections
- Female patients who are pregnant, breast-feeding, or possibly pregnant.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriatic Erythroderma
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Pustular Psoriasis (Excluding a Localized)
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Psoriatic Arthritis
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Plaque Psoriasis
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Intervention(s)
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Drug: TA-650
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Primary Outcome(s)
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Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
[Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period]
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Secondary Outcome(s)
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Assessment of Severity (Only for Patients With Pustular Psoriasis)
[Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period]
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Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
[Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period]
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Psoriasis Area and Severity Index (PASI) Score
[Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period]
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Visual Analog Scale(VAS) of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
[Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period]
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Secondary ID(s)
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TA-650-24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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