Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment acitretin
Phase phase 2
Sponsor University of Medicine and Dentistry of New Jersey
Collaborator Connetics Corp.
Start date September 2005
End date June 2009
Trial size 10 participants
Trial identifier NCT00156247, 5487

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
open-label
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Percent of patients achieving PASI 50 at 6 months after the addition of acitretin therapy
time frame: 6 months
Percent of patients achieving a PGA of clear or almost clear at 6 months after the addition of acitretin therapy
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Melissa A. Magliocco, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.