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Acitretin and Etanercept in Psoriasis

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ClinicalTrials.gov Identifier: NCT00156247
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: acitretin Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: etanercept with acitretin
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.
Other Name: Soriatane


Outcome Measures

Primary Outcome Measures :
  1. Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy [ Time Frame: 6 months ]
    Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.


Secondary Outcome Measures :
  1. Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy [ Time Frame: 6 months ]
    Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.

  2. Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy [ Time Frame: 6 months ]
    Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156247


Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Connetics Corp.
Investigators
Principal Investigator: Melissa A. Magliocco, MD Rutgers, The State University of New Jersey
More Information

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00156247     History of Changes
Other Study ID Numbers: 5487
First Posted: September 12, 2005    Key Record Dates
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
psoriasis
etanercept
acitretin

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Acitretin
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
Immunosuppressive Agents
Immunologic Factors
Keratolytic Agents
Dermatologic Agents