Clinical trial NCT01435265: Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
Official title: The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
Dermatology
Phase IV
Nurse Education
Adalimumab
Humira
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Change in Psoriasis Area Severity Index (PASI-75)
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
measure: Investigator's Global Assessment (IGA) of Psoriasis
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to Adalimumab Treatment
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: