Psoriasis
Conditions
Keywords
psoriasis, tacrolimus, etanercept
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.
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.
Interventions
DRUGEtanercept plus tacrolimus
Sponsors
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Photography of target lesions | — |
| Quarter-body photography | — |
| Static Physician's Global Assessment (PGA) on each side of each subject's body | — |
Countries
United States
Outcome results
None listed