Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 3
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00237887
- Lead Sponsor
- Abbott
- Brief Summary
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1212
Inclusion Criteria
- Subject was age 18 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, had moderate to severe plaque psoriasis.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections
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 UVB or PUVA phototherapy
- Subject cannot avoid excessive sun exposure
- 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 achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score Week 16
- Secondary Outcome Measures
Name Time Method Safety parameters