Psoriasis
Conditions
Brief summary
The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.
Interventions
DRUGHuman anti-TNF monoclonal antibody adalimumab/ up to 24 weeks
Sponsors
Eisai Limited
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 injectable corticosteroids * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinical response relative to Baseline PASI score | — |
Secondary
| Measure | Time frame |
|---|---|
| QoLs | — |
| Clinical response indicators | — |
| Safety parameters | — |
Countries
Japan
Outcome results
None listed