Status:
COMPLETED
Acitretin and Etanercept in Psoriasis
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Connetics Corp.
Conditions:
Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
Detailed Description
This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitret...
Eligibility Criteria
Inclusion
- Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 \[moderate\] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept
- All patients on etanercept have been tested for TB before initiation of etanercept
Exclusion
- Patients \< 18 years old or \> 80 years old
- Patients who are not on etanercept 50 mg SQ once weekly
- Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile \[bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation\] or post-menopausal for at least 2 years, are eligible)
- Inability to understand consent or comply with study requirements
- Uncontrolled hypertriglyceridemia
- Patients with severely impaired hepatic function
- Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests
- Systemic psoriasis therapies or PUVA within the past 2 weeks
- UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week
- Patients with epilepsy or multiple sclerosis
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00156247
Start Date
September 1 2005
End Date
March 1 2009
Last Update
February 16 2015
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