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Biological Response Modifier
Etanercept for Psoriasis
Phase 4
Waitlist Available
Led By Orit Markowitz, MD
Research Sponsored by OptiSkin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
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).
Eligible Conditions
- Psoriasis
- Psoriatic Arthritis
- Psoriatic Nails
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NAPSI
OCT (clinical)
Secondary study objectives
Dermoscopy
OCT (sub-clinical)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EtanerceptExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4720
OCT
2016
N/A
~1270
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Who is running the clinical trial?
OptiSkin MedicalLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
AmgenIndustry Sponsor
1,431 Previous Clinical Trials
1,385,186 Total Patients Enrolled
76 Trials studying Psoriasis
116,500 Patients Enrolled for Psoriasis
Orit Markowitz, MDPrincipal InvestigatorOptiSkin Medical
2 Previous Clinical Trials
36 Total Patients Enrolled
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