Acitretin and Etanercept in Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156247
• Other study ID #: 5487
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: February 13, 2015
• Start date: September 2005
• Est. completion date: March 2009

Study information

• Verified date: February 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Connetics Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy	Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.	6 months	No
Secondary	Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy	Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.	6 months	No
Secondary	Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy	Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.	6 months	No