Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging

Study Overview
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Brief Summary
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OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).

Detailed Description
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Psoriasis often affects the fingernails, making them yellow, brittle, painful and prone to infections. These symptoms can be difficult to manage, so OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT). OCT is being studied as a way to better diagnosis psoriatic nail disease, monitor response to therapy, and identify changes even before they become apparent, potentially leading to earlier treatment or prevention of future psoriatic arthritis. Study-related care and medication are provided at no cost, and reimbursement for reasonable local transportation may be available to qualified individuals.

Official Title
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Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography

Conditions
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Psoriasis, Psoriatic Arthritis, Psoriatic Nail

Intervention / Treatment
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* Drug: Etanercept
* Device: OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe psoriasis Psoriasis affecting the fingernails Exclusion Criteria: Previous treatment with Enbrel® (etanercept) Active infection Rheumatoid arthritis Any personal or family history of any neurologic demyelinating disease Receipt of investigational drugs or biologics within 4 weeks of the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Etanercept<br>50mg etanercept subcutaneously twice weekly for 3 months, followed by once weekly for another 3 months for a total duration of 6 months or 24 weeks. | Drug: Etanercept<br>* TNF-alpha inhibitors improve nail psoriasis.<br>* Other names: Enbrel;Device: OCT<br>* Optical Coherence Tomography is a noninvasive imaging device that can be used to monitor nail disease severity.<br>* Other names: Optical Coherence Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAPSI | Nail Psoriasis Severity Index (NAPSI) score is an established measure of nail disease ranging from 0-100. A higher score indicates more severe nails psoriasis. | Baseline to 24 weeks | 
| OCT (clinical) | Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity. | Baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT (sub-clinical) | Optical Coherence Tomography is noninvasive imaging that will be used to detect subclinical changes in otherwise healthy-appearing nails. | Baseline to 24 weeks | 
| Dermoscopy | Dermoscopy allows for the examination of the skin using skin surface microscopy. | Baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis Nails, Psoriatic Arthritis, Enbrel, Biologic