Acitretin and Etanercept in Psoriasis

Condition(s) targeted: Psoriasis

Intervention: acitretin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Medicine and Dentistry New Jersey

Official(s) and/or principal investigator(s):
Melissa A. Magliocco, MD, Principal Investigator, Affiliation: University of Medicine and Dentistry New Jersey

Overall contact:
Irina Lipets, RN, BSN, Phone: 732-253-5737, Email: lipetsir@umdnj.edu

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

Official title: Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: Percent of patients achieving PASI 75 at 6 months after the addition of acitretin therapy

Secondary outcome:

Percent of patients achieving PASI 50 at 6 months after the addition of acitretin therapy

Percent of patients achieving a PGA of clear or almost clear at 6 months after the addition of acitretin therapy

Detailed description: This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults (aged 18 to 80 years) 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

Irina Lipets, RN, BSN, Phone: 732-253-5737, Email: lipetsir@umdnj.edu

UMDNJ Division of Clinical Pharmacology, New Brunswick, New Jersey 08901, United States; Recruiting
Patricia Hanas, Phone: 732-235-8063, Email: hanaspw@umdnj.edu

Starting date: September 2005
Ending date: April 2007
Last updated: February 13, 2008