Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
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.
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.
Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI
Methotrexate >7. 5 mg/week for the last 3 months
Predominantly guttate, erythrodermic or pustular psoriasis
Other skin conditions than psoriasis
Locations and Contacts
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