Acitretin and Etanercept in Psoriasis

NCT ID: NCT00156247

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-03-31

Brief Summary

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

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

etanercept with acitretin

open-label

Group Type: EXPERIMENTAL

acitretin

Intervention Type: DRUG

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.

Interventions

acitretin

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.

Intervention Type: DRUG

Other Intervention Names

Soriatane

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connetics Corp.

UNKNOWN

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa A. Magliocco, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Other Identifiers

5487

Identifier Type: -

Identifier Source: org_study_id