Acitretin and Etanercept in Psoriasis

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: acitretin

Study type: Interventional

Funder types: Other

Identifiers

NCT00156247

5487

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

etanercept with acitretin

Experimental group

Description:

open-label

Treatment:

Drug: acitretin