Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab

NCT01435265 | Completed Results

• 1 other identifier: IRB00009876
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Dermatology; Phase IV; Nurse Education; Adalimumab; Humira

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Adherence to Adalimumab Treatment

  Baseline to 12 months

Study Arms (2)

Normal Nurse Education

ACTIVE COMPARATOR

Subjects receive normal nurse education materials provided by their physician.

Behavioral: Standard nurse education

Additional Nurse Education-

EXPERIMENTAL

Subjects will receive additional nurse education beyond the normal education materials provided by their physician

Behavioral: Standard nurse education; Behavioral: Additional nurse education

Interventions

Standard nurse education BEHAVIORAL

Standard-of-care education from a dermatology nurse on the proper use of adalimumab

Additional Nurse Education-; Normal Nurse Education

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.

Additional Nurse Education-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Steven Feldman, MD, PhD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-7740

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 16, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 29, 2018
• Results First Posted: March 5, 2013

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)