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Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab | Clinical Trials | Clareo Health

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Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab

The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab

NCT01435265•Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

Detailed Description

This is a phase IV randomized, prospective open label study to asses the efficacy of an extended nurse eduction program in improving adherence to the prescribed treatment regimen in the treatment of moderate to severe psoriasis vulgaris. Twenty subjects, male or female, ages 18 and older in good health with moderate to severe chronic plaque type psoriasis for whom adalimumab is indicated according to the adalimumab prescribing information. All subjects must have a negative TB skin test according to prescribing guidelines. Subjects must be starting adalimumab for the first time, prescribed by their physician. This is an open label trial. All subjects will be receiving adalimumab as prescribed by their physician. Half the group will be randomized to receive the additional nurse education program, the other half will receive the normal education materials provided by their physician.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be male or female, 18 years of age or greater, in good health with moderate to severe plaque psoriasis for whom adalimumab is indicated according to the adalimumab prescribing information.
•All subjects must have a negative TB skin test according to prescribing guidelines.
•Subjects must be starting adalimumab for the first time, prescribed by their dermatologist.
•Must give written informed consent.
•Subject must be adult males or non-pregnant , non-lactating females.
•Female subjects of childbearing potential must state that they are using measures to avoid conception through active means including, abstinence, oral contraceptives, intrauterine device, Depo-Provera, Norplant, tubal ligation, or vasectomy of the partner in a monogamous relationship.
•Subjects may not be on concomitant systemic medications for their psoriasis such as methotrexate, acitretin, etretinate, cyclosporine, prednisone ot other biological agents or receiving phototherapy at the baseline visit, but no specific washout of these treatments will be required.
•There is no washout for topical medications. Stable dosing of topical medications may be used throughout the duration of the study.

Exclusion Criteria

•Subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation.
•Subjects who have a history of hypersensitivity to adalimumab or history of hypersensitivity to any of the formulation components will be excluded from the study.
•Female subjects who are not postmenopausal for at least one year, surgically sterile or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
•Current enrollment in any research study involving an investigational drug.
•Serious local infection or systemic infection within the three months prior to the first dose of investigational drug.
•Treatment with another investigational drug within one month prior to study drug administration.
•Concurrent treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab or mofetil or other systemic immunosuppressant agents.
•Any active or history of HIV, Hepatitis or tuberculosis

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

August 29, 2018

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Standard nurse education

BEHAVIORAL

Additional nurse education

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments