Status:
COMPLETED
Etanercept With Tacrolimus for Psoriasis
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 oint...
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00134394
Start Date
February 1 2005
End Date
December 1 2007
Last Update
August 7 2008
Active Locations (1)
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1
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903