PsoriasisNCT01435265
Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
A study testing Standard nurse education and Additional nurse education in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Standard nurse education and Additional nurse education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Standard nurse education, Additional nurse education
- Keywords
- Psoriasis, Dermatology, Phase IV, Nurse Education, Adalimumab, Humira
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard nurse educationBehavioural
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
Additional nurse educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Nurse Education | Active comparator | Subjects receive normal nurse education materials provided by their physician. Receives: Behavioral: Standard nurse education |
| Additional Nurse Education- | Experimental | Subjects will receive additional nurse education beyond the normal education materials provided by their physician Receives: Behavioral: Standard nurse education; Behavioral: Additional nurse education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 months
Secondary outcomes (1)
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435265
- Sponsor's protocol ID
- IRB00009876
- Status last verified
- Jul 2018
- First submitted
- 13 Sep 2011
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab
- ClinicalTrials.gov ID
- NCT01435265
- Acronym / sponsor ID
- IRB00009876
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Dermatology, Phase IV, Nurse Education, Adalimumab, Humira
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Posted 5 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Nurse Education | Active comparator | Behavioral: Standard nurse educationSubjects receive normal nurse education materials provided by their physician. |
| Additional Nurse Education- | Experimental | Behavioral: Standard nurse education, Behavioral: Additional nurse educationSubjects will receive additional nurse education beyond the normal education materials provided by their physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard nurse educationStandard-of-care education from a dermatology nurse on the proper use of adalimumab | Behavioural | Additional Nurse Education-, Normal Nurse Education |
| Additional nurse educationAdditional 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. | Behavioural | Additional Nurse Education- |
Primary outcome
Change in Psoriasis Area Severity Index (PASI-75)
Time frame: 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
Time frame: 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).
1 secondary outcome
Adherence to Adalimumab Treatment
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard nurse education and Additional nurse education in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area Severity Index (PASI-75) (time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.