Etanercept With Tacrolimus for Psoriasis

University of Medicine and Dentistry of New Jersey

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: Etanercept plus tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00134394

5085

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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