Acitretin and Etanercept in Psoriasis

Original Study ID : 5487

NCT ID : NCT00156247

Brief Title : Acitretin and Etanercept in Psoriasis

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

Brief Summary :

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

Source : University of Medicine and Dentistry New Jersey

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 25 mg/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.

Overall Status : Active, not recruiting

Start Date : September 2005

End Date : April 2007

Completion Date : April 2007

Official Title : Phase 2

Phase : Interventional

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

Enrollment : 10

Verification Date : October 2008

First Received Date : September 7, 2005

Trial Eligibility

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

Gender : Both

Minimum Age : 18 Years

Maximum Age : 80 Years

Healthy Volunteers : No

Facilities

Facility Name : UMDNJ Division of Clinical Pharmacology

City : New Brunswick

State : New Jersey

Zip Code : 08901

Country : United States

OutComes

Primary OutComes

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

Time Frame : 6 months

Safety issue : No

Secondary OutComes

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

Time Frame : 6 months

Safety issue : No

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

Time Frame : 6 months

Safety issue : No

Interventions

Type : Drug

Name : acitretin

Description : Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.

Clinical Trial Name - Acitretin and Etanercept in Psoriasis