Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Abbott

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Drug: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

M03-656

Details and patient eligibility

About

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

Enrollment

1,212 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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