Acitretin and Etanercept in Psoriasis - Full Text View

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

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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:

MedlinePlus related topics: Psoriasis

Drug Information available for: Acitretin Etanercept

U.S. FDA Resources

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 Study Completion Date:	April 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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:	UMDNJ-RWJMS ( Melissa Magliocco, MD )
Study ID Numbers:	5487
Study First Received:	September 7, 2005
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00156247 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

psoriasis
etanercept
acitretin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Keratolytic Agents
Psoriasis
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous
Acitretin
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010