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 Rutgers, The State University of New Jersey.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Connetics Corp.
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00156247
First received: September 7, 2005
Last updated: November 5, 2008
Last verified: October 2008
  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 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 ]

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
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

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 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: 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 Rutgers, The State University of 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 August 28, 2014