Acitretin and Etanercept in Psoriasis

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: Connetics Corp.
• Treatments: Acitretin; Etanercept

Criteria

Inclusion Criteria:

• Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept

• All patients on etanercept have been tested for TB before initiation of etanercept

Exclusion Criteria:

• Patients < 18 years old or > 80 years old

• Patients who are not on etanercept 50 mg SQ once weekly

• Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible)

• Inability to understand consent or comply with study requirements

• Uncontrolled hypertriglyceridemia

• Patients with severely impaired hepatic function

• Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests

• Systemic psoriasis therapies or PUVA within the past 2 weeks

• UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week

• Patients with epilepsy or multiple sclerosis