Etanercept With Tacrolimus for Psoriasis

This study has been completed.

Sponsor:

Information provided by:

University of Medicine and Dentistry New Jersey

ClinicalTrials.gov Identifier:

NCT00134394

First received: August 22, 2005

Last updated: August 6, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

August 6, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

· 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.

Change History

Complete list of historical versions of study NCT00134394 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Etanercept With Tacrolimus for Psoriasis

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Etanercept plus tacrolimus

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00134394

Other Study ID Numbers ^ICMJE

5085

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Melissa Magliocco, MD

UMDNJ - RWJMS

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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