Phase 2
N=9
Acitretin and Etanercept in Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00156247 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy — 12.5 percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- acitretin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy |
12.5 | — |
| SECONDARY Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy |
50 | — |
| SECONDARY Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy |
37.5 | — |
Summary
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Patients 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
Data sourced from ClinicalTrials.gov (NCT00156247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.