Acitretin and Etanercept in Psoriasis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Medicine and Dentistry New Jersey.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Connetics Corp.
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00156247
First received: September 7, 2005
Last updated: November 5, 2008
Last verified: October 2008
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Purpose
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: acitretin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Percent of patients achieving PASI 75 at 6 months after the addition of acitretin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
open-label
|
Drug: acitretin
Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 < 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156247
Locations
| United States, New Jersey | |
| UMDNJ Division of Clinical Pharmacology | |
| New Brunswick, New Jersey, United States, 08901 | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Connetics Corp.
Investigators
| Principal Investigator: | Melissa A. Magliocco, MD | University of Medicine and Dentistry New Jersey |
More Information
No publications provided
| Responsible Party: | Melissa Magliocco, MD, UMDNJ-RWJMS |
| ClinicalTrials.gov Identifier: | NCT00156247 History of Changes |
| Other Study ID Numbers: | 5487 |
| Study First Received: | September 7, 2005 |
| Last Updated: | November 5, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
psoriasis etanercept acitretin |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Acitretin TNFR-Fc fusion protein Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013