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Etanercept With Tacrolimus for Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etanercept plus tacrolimus
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, tacrolimus, etanercept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location Exclusion Criteria Inability to understand consent or comply with study requirements Pregnancy or unwillingness to use adequate birth control method Lactation Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months) Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks Active tuberculosis or other opportunistic infection Demyelinating disease Uncontrolled congestive heart failure Known allergy to or any contraindications to using topical tacrolimus or etanercept Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR

Sites / Locations

  • UMDNJ Psoriasis Center of Excellence

Outcomes

Primary Outcome Measures

Target lesion scoring (on a scale of 0-12) at week 12
The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.

Secondary Outcome Measures

Photography of target lesions
Quarter-body photography
Static Physician's Global Assessment (PGA) on each side of each subject's body

Full Information

First Posted
August 22, 2005
Last Updated
August 6, 2008
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00134394
Brief Title
Etanercept With Tacrolimus for Psoriasis
Official Title
Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.
Detailed Description
The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, tacrolimus, etanercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Etanercept plus tacrolimus
Primary Outcome Measure Information:
Title
Target lesion scoring (on a scale of 0-12) at week 12
Title
The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
Secondary Outcome Measure Information:
Title
Photography of target lesions
Title
Quarter-body photography
Title
Static Physician's Global Assessment (PGA) on each side of each subject's body

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location Exclusion Criteria Inability to understand consent or comply with study requirements Pregnancy or unwillingness to use adequate birth control method Lactation Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months) Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks Active tuberculosis or other opportunistic infection Demyelinating disease Uncontrolled congestive heart failure Known allergy to or any contraindications to using topical tacrolimus or etanercept Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Magliocco, MD
Organizational Affiliation
UMDNJ - RWJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ Psoriasis Center of Excellence
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Etanercept With Tacrolimus for Psoriasis

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