Etanercept With Tacrolimus for Psoriasis
Completed · Phase 2
Conditions studied: Psoriasis
In brief
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.
Key facts
- Study ID
- NCT00134394
- Run by
- University of Medicine and Dentistry of New Jersey
- People needed
- 20
- Starts
- 2005-02-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2008-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UMDNJ Psoriasis Center of Excellence — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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