NCT00156247

Brief Summary

To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
6 years until next milestone

Results Posted

Study results publicly available

February 16, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

September 7, 2005

Results QC Date

July 11, 2011

Last Update Submit

February 13, 2015

Conditions

Psoriasis

Keywords

psoriasisetanerceptacitretin

Outcome Measures

Primary Outcomes (1)

  • Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy

    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.

    6 months

Secondary Outcomes (2)

  • Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy

    6 months

  • Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy

    6 months

Study Arms (1)

etanercept with acitretin

EXPERIMENTAL

open-label

Drug: acitretin

Interventions

acitretinDRUG

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.

Also known as: Soriatane
etanercept with acitretin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Limitations and Caveats

small sample size; lack of control group

Results Point of Contact

Title
Melissa Magliocco, MD
Organization
UMDNJ-Robert Wood Johnson Medical School
maglioma@umdnj.edu
(732) 235-5735

Study Officials

  • Melissa A. Magliocco, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 16, 2015

Results First Posted

February 16, 2015

Record last verified: 2015-02