Etanercept With Tacrolimus for Psoriasis

Original Study ID : 5085

NCT ID : NCT00134394

Brief Title : Etanercept With Tacrolimus for Psoriasis

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

Brief 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.

Source : University of Medicine and Dentistry New Jersey

Detailed 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.

Overall Status : Completed

Start Date : February 2005

End Date : December 2007

Completion Date : December 2007

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Enrollment : 20

Verification Date : August 2008

First Received Date : August 22, 2005

Trial Eligibility

Criteria :
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : UMDNJ Psoriasis Center of Excellence

City : New Brunswick

State : New Jersey

Zip Code : 08903

Country : United States

OutComes

Primary OutComes

Secondary OutComes

Measure : Photography of target lesions

Measure : Quarter-body photography

Measure : Static Physician's Global Assessment (PGA) on each side of each subject's body

Interventions

Type : Drug

Name : Etanercept plus tacrolimus

Clinical Trial Name - Etanercept With Tacrolimus for Psoriasis