Psoriasis
Conditions
Keywords
Psoriasis, Dermatology, Phase IV, Nurse Education, Adalimumab, Humira
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.
Interventions
BEHAVIORALStandard nurse education
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
BEHAVIORALAdditional 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psoriasis Area Severity Index (PASI-75) | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | 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 | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Adalimumab Treatment | Baseline to 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Nurse Education Subjects receive normal nurse education materials provided by their physician. | 3 |
| Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Additional Nurse Education- | Normal Nurse Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Continuous | 55.0 years STANDARD_DEVIATION 9.3 | 46.7 years STANDARD_DEVIATION 12.7 | 51.4 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 3 / 3 | 4 / 4 |
Outcome results
Primary
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.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: All participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Nurse Education | Change in Psoriasis Area Severity Index (PASI-75) | 1 participants |
| Additional Nurse Education- | Change in Psoriasis Area Severity Index (PASI-75) | 3 participants |
Primary
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).
Time frame: 12 months
Population: All participants completing the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Nurse Education | Investigator's Global Assessment (IGA) of Psoriasis | 0 participants |
| Additional Nurse Education- | Investigator's Global Assessment (IGA) of Psoriasis | 1 participants |
Secondary
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.
Time frame: Baseline to 12 months
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Nurse Education | Adherence to Adalimumab Treatment | 19.0 days | Standard Deviation 9.8 |
| Additional Nurse Education- | Adherence to Adalimumab Treatment | 17.7 days | Standard Deviation 12.1 |