Etanercept With Tacrolimus for Psoriasis

Psoriasis Clinical Trial

Official title:

Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134394
• Other study ID #: 5085
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: August 6, 2008
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• 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

The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.

Description:

The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body

• Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria

• Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location

Exclusion Criteria

• Inability to understand consent or comply with study requirements

• Pregnancy or unwillingness to use adequate birth control method

• Lactation

• Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months)

• Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks

• Active tuberculosis or other opportunistic infection

• Demyelinating disease

• Uncontrolled congestive heart failure

• Known allergy to or any contraindications to using topical tacrolimus or etanercept

• Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept plus tacrolimus

Locations

Country	Name	City	State
United States	UMDNJ Psoriasis Center of Excellence	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion scoring (on a scale of 0-12) at week 12
Primary	The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
Secondary	Photography of target lesions
Secondary	Quarter-body photography
Secondary	Static Physician's Global Assessment (PGA) on each side of each subject's body