Patients with psoriasis who are already using a stable dose of etanercept (or about to start treatment) will be supplied with tacrolimus and placebo ointments. They will be asked to apply the ointments (placebo on one side and drug on the other) to all lesions twice a day. A 12 week commitment is required.

Condition	Intervention	Phase
Psoriasis	Drug: Etanercept plus tacrolimus	Phase II

Further Study Details: 

Primary Outcomes: · Target lesion scoring (on a scale of 0-12) at week 12. The percentage of lesions having scores of <2 in the topical tacrolimus and vehicle-treated sites will be assessed.
Secondary Outcomes: · Photography of target lesions; · Quarter-body photography; · Static Physician’s Global Assessment (PGA) on each side of each subject’s body.
Expected Total Enrollment:  20

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00134394

New Jersey
      UMDNJ Clinical Research Center, New Brunswick,  New Jersey,  08903,  United States; Recruiting

Study chairs or principal investigators

Melissa Magliocco, MD,  Principal Investigator,  UMDNJ - RWJMS   

Study ID Numbers:  5085
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134394
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30