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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Behavioral: Standard nurse education; Behavioral: Additional nurse education

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal Nurse Education; Subjects receive normal nurse education materials provided by their physician.	Behavioral: Standard nurse education; Standard-of-care education from a dermatology nurse on the proper use of adalimumab
Experimental: Additional Nurse Education-; Subjects will receive additional nurse education beyond the normal education materials provided by their physician	Behavioral: Standard nurse education; Standard-of-care education from a dermatology nurse on the proper use of adalimumab; Behavioral: Additional nurse education; Additional education from a nurse on the use of adalimumab. This will include discussion of the pre-study evaluation with the subject, design of an Individual Educational Plan based on the pre-study evaluation, and a 30-60 minute educational session with the nurse educator at each study visit. Additional information concerning the benefits of the local support group and National Psoriasis Foundation will be provided. Additional education on self-injection and the opportunity to practice self-injection under the supervision of a nurse will also be provided. Subjects will also receive reminder phone calls to take each scheduled dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psoriasis Area Severity Index (PASI-75)	The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Investigator's Global Assessment (IGA) of Psoriasis	Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Adalimumab Treatment	Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 16, 2011

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis; Phase IV; Adalimumab; Dermatology; Humira; Nurse Education
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IRB00009876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No