Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 2
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00338754
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects with clinical response relative to Baseline PASI score
- Secondary Outcome Measures
Name Time Method QoLs Clinical response indicators Safety parameters