| September 7, 2005 |
| November 5, 2008 |
| September 2005 |
| June 2009 (final data collection date for primary outcome measure) |
| Percent of patients achieving PASI 75 at 6 months after the addition of acitretin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| · Percent of patients achieving PASI 75 at 6 months after the addition of acitretin therapy |
| Complete list of historical versions of study NCT00156247 on ClinicalTrials.gov Archive Site |
- Percent of patients achieving PASI 50 at 6 months after the addition of acitretin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percent of patients achieving a PGA of clear or almost clear at 6 months after the addition of acitretin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|
- · Percent of patients achieving PASI 50 at 6 months after the addition of acitretin therapy
- · Percent of patients achieving a PGA of clear or almost clear at 6 months after the addition of acitretin therapy
|
| |
| Acitretin and Etanercept in Psoriasis |
| Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy |
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults. |
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 acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Psoriasis |
| Drug: acitretin |
| Experimental: open-label |
| |
| |
| Active, not recruiting |
| 10 |
| April 2007 |
| June 2009 (final data collection date for primary outcome measure) |
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 < 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
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00156247 |
| Melissa Magliocco, MD, UMDNJ-RWJMS |
| 5487 |
| University of Medicine and Dentistry New Jersey |
| Connetics Corp. |
| Principal Investigator: |
Melissa A. Magliocco, MD |
University of Medicine and Dentistry New Jersey |
|
|
| University of Medicine and Dentistry New Jersey |
| October 2008 |
