Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Condition(s) targeted: Psoriasis; Arthritis, Psoriatic

Intervention: Etanercept (Drug); Methotrexate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth Research

The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.

Official title: A Multicenter, Open-Label, Randomized, Pilot-Study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary outcome:

Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75

and 90. Time to clear or almost clear on PGA.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8. Methotrexate >7. 5 mg/week for the last 3 months Exclusion Criteria: Predominantly guttate, erythrodermic or pustular psoriasis Other skin conditions than psoriasis

Helsinki, Finland

Tampere, Finland

Fredriksberg Alle, Copenhagen, Denmark

Lakarhuset Fasta Centrum, Farsta, Sweden

Gentofte Amtsygehus, Hellerup, Denmark

Rikshospitalet, Olso, Norway

Hudlegekontoret Akutten, Tromso, Norway

Lakarhuset, Vallingby, Sweden

Starting date: April 2005
Last updated: March 21, 2007