Overview

Etanercept With Tacrolimus for Psoriasis

Status:
Completed

Trial end date:
2007-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Treatments:

Etanercept
Tacrolimus

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