Status:
COMPLETED
Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01435265
Start Date
January 1 2010
End Date
April 1 2012
Last Update
August 29 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157