JRCT ID: jRCT2080220270
Registered date:07/07/2006
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Psoriasis |
Date of first enrollment | 07/07/2006 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneous control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Subcutaneous |
Outcome(s)
Primary Outcome | Proportion of subjects with clinical response relative to Baseline PASI score |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Inclusion criteria: - Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history. - Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis Exclusion criteria: - Subject had previously received anti-TNF therapy. - Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy - Subject is taking or requires oral or injectible corticosteriods - Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study - Female subject who is pregnant or breast-feeding or considering becoming pregnant |
Exclude criteria |
Related Information
Primary Sponsor | Abbott Japan Co., Ltd. |
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Secondary Sponsor | Eisai Co., Ltd. |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-060275 |
Contact
Public contact | |
Name | |
Address | E-mail: ABTJ-CTR@abbott.com |
Telephone | |
Affiliation | Abbott Japan Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |