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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Nurse Education | Active Comparator | Subjects receive normal nurse education materials provided by their physician. |
|
| Additional Nurse Education- | Experimental | Subjects will receive additional nurse education beyond the normal education materials provided by their physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard nurse education | Behavioral | Standard-of-care education from a dermatology nurse on the proper use of adalimumab |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Nurse Education | Subjects receive normal nurse education materials provided by their physician. |
| FG001 | Additional Nurse Education- | Subjects will receive additional nurse education beyond the normal education materials provided by their physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Nurse Education | Subjects receive normal nurse education materials provided by their physician. |
| BG001 | Additional Nurse Education- | Subjects will receive additional nurse education beyond the normal education materials provided by their physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed the study. | Posted | Number | participants | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Nurse Education | Subjects receive normal nurse education materials provided by their physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest University Health Sciences | 336-716-7740 | sfeldman@wakehealth.edu |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Additional nurse education | Behavioral | 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. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Additional Nurse Education- |
Subjects will receive additional nurse education beyond the normal education materials provided by their physician |
|
|
| 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). | All participants completing the study. | Posted | Number | participants | 12 months |
|
|
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| 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. | All participants | Posted | Mean | Standard Deviation | days | Baseline to 12 months |
|
|
|
| 3 |
| 3 |
| 0 |
| 3 |
| EG001 | Additional Nurse Education | Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician | 4 | 4 | 0 | 4 |
| Abscess on R lower leg | Infections and infestations | Non-systematic Assessment |
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| Blurry/Double vision | Eye disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Elevated Blood sugar | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Elevated transaminases | Hepatobiliary disorders | Non-systematic Assessment |
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| Fall-Fractured clavicle and great toe | General disorders | Non-systematic Assessment |
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| Fatty Liver | Hepatobiliary disorders | Non-systematic Assessment |
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| Fibroid tumor | Reproductive system and breast disorders | Non-systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hot and Cold Flashes | General disorders | Non-systematic Assessment |
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| Increased forehead wrinkling and perioral pigment changes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Intestinal abscess | Gastrointestinal disorders | Non-systematic Assessment |
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| Mild Hepatic Steatosis | Hepatobiliary disorders | Non-systematic Assessment |
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| Orthostatic Hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Ovarian Cyst | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pain in L lower back radiating to L leg (muscle strain per PCP) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Possible Keratocanthoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Productive Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Psoriatic arthritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Severe Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sinus Infection | General disorders | Non-systematic Assessment |
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| Sinus drainage | General disorders | Non-systematic Assessment |
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| Thickening of Cervical Lining | Reproductive system and breast disorders | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Vaginal yeast infection | Reproductive system and breast disorders | Non-systematic Assessment |
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| Worsening of alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| coryza | Infections and infestations | Non-systematic Assessment |
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| excessive drowsiness/sleepiness | General disorders | Non-systematic Assessment |
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| recurrent squamous cell carcinoma on R ventral forearm | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Injection Site Reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Abscess on L side | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Psychiatric Hospitalization | Psychiatric disorders | Non-systematic Assessment | hospitalization for mental abuse from spouse |
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