Acitretin and Etanercept in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Connetics Corp.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00156247
First received: September 7, 2005
Last updated: February 13, 2015
Last verified: February 2015
  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: Endpoint Classification: Efficacy Study
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 Rutgers, The State University of 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 ]
    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:
  • Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • 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 ]
    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.


Enrollment: 10
Study Start Date: September 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00156247     History of Changes
Other Study ID Numbers: 5487
Study First Received: September 7, 2005
Results First Received: July 11, 2011
Last Updated: February 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
psoriasis
etanercept
acitretin

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Acitretin
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Keratolytic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015