Back to resultsNurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard nurse education
Additional nurse education
Sponsored by
About this trial
This is an interventional health services research trial for Psoriasis focused on measuring Psoriasis, Dermatology, Phase IV, Nurse Education, Adalimumab, Humira
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
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal Nurse Education
Additional Nurse Education-
Arm Description
Subjects receive normal nurse education materials provided by their physician.
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01435265
First Posted
September 13, 2011
Last Updated
July 30, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01435265
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Dermatology, Phase IV, Nurse Education, Adalimumab, Humira
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Nurse Education
Arm Type
Active Comparator
Arm Description
Subjects receive normal nurse education materials provided by their physician.
Arm Title
Additional Nurse Education-
Arm Type
Experimental
Arm Description
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
Intervention Type
Behavioral
Intervention Name(s)
Standard nurse education
Intervention Description
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
Intervention Type
Behavioral
Intervention Name(s)
Additional nurse education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Psoriasis Area Severity Index (PASI-75)
Description
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.
Time Frame
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Title
Investigator's Global Assessment (IGA) of Psoriasis
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adherence to Adalimumab Treatment
Description
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.
Time Frame
Baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
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