A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Abbott0 sites1,212 target enrollmentDecember 2004

ConditionsPsoriasis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Abbott
Enrollment: 1212
Primary Endpoint: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score
Status: Completed
Last Updated: 18 years ago

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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

•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