Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01200264
Status:
WITHDRAWN
Last Update Posted:
2014-07-15
First Post:
2010-09-10
Brief Title:
Apremilast for Chronic Plaque Psoriasis CPP Patients Who Have Failed One Course of Biologic Therapy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy
Status:
WITHDRAWN
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Contract never executed withdrawn by sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II open label investigator-initiated study to be done at Duke University Medical Center to treat adult patients ages 18-80 with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks At the time of enrollment the patient must have received biologic therapy without achieving a response of almost clear or clear according to PGA or has not responded with a 75 reduction of PASI score Once deemed eligible subjects will return for a baseline visit and receive Apremilast therapy and instructions Subjects will be treated at weeks 048121620 and 24 subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy
Detailed Description:
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study All subsequent data collected will be analyzed and reported in a follow-up clinical report
Data Safety Monitoring Dr Murray will be following all laboratory values and adverse events during this trial In addition Celgene will provide a study monitor to at regular intervals review all data All data will be reported to Celgene
Data Safety Monitoring Dr Murray will be following all laboratory values and adverse events during this trial In addition Celgene will provide a study monitor to at regular intervals review all data All data will be reported to Celgene
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AP00039 | None | None | None |