Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT02558361
Status:
WITHDRAWN
Last Update Posted:
2016-10-21
First Post:
2015-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Apremilast in Patients With Psoriatic Arthritis
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
A Skin and Synovial Tissue Assessment of Overlapping Genes and Their Response After 3 Months Treatment With Apremilast in Patients With Psoriatic Arthritis
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA approved synovial biopsy device unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.
Detailed Description:
Purpose of the study Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin. They also provide no data regarding the timing of response in the target organs.
Because of these limitations in the existing literature, a study assessing the response to apremilast in synovial (joint) tissue and skin is needed. This will be a small study assessing the inflammatory response in the synovial (joint) tissue and skin samples from patients with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
We are asking you to take part in this research study because you have both psoriasis and psoriatic arthritis. Both conditions are active and you are an appropriate candidate to be treated with apremilast, i.e. this same treatment would be offered to you if you were not to enroll in this study. You are also an appropriate candidate to receive skin and synovial (joint) tissue biopsies. We want to find out how specific proteins in your skin and synovial (joint) tissue that are responsible for the inflammation associated with psoriasis and psoriatic arthritis respond to treatment with apremilast.
Study Procedures: What will happen during this study?
This study will consist of three study visits over a period of three months. If appropriate, you will be started on apremilast at your first study visit. This is part of your standard of care. The dose of apremilast you will receive will be the normal FDA-approved dose. You will not receive a placebo (sugar) pill. Everyone who participates in the study will be treated with apremilast. The study procedures that will take place at each of the three visits are listed below:
Baseline Visit:
Review inclusion/exclusion criteria Medical history obtained by the study nurse A physical examination by the study doctor Obtain blood and urine samples with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin. They also provide no data regarding the timing of response in the target organs.
Because of these limitations in the existing literature, a study assessing the response to apremilast in synovial (joint) tissue and skin is needed. This will be a small study assessing the inflammatory response in the synovial (joint) tissue and skin samples from patients with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
We are asking you to take part in this research study because you have both psoriasis and psoriatic arthritis. Both conditions are active and you are an appropriate candidate to be treated with apremilast, i.e. this same treatment would be offered to you if you were not to enroll in this study. You are also an appropriate candidate to receive skin and synovial (joint) tissue biopsies. We want to find out how specific proteins in your skin and synovial (joint) tissue that are responsible for the inflammation associated with psoriasis and psoriatic arthritis respond to treatment with apremilast.
Study Procedures: What will happen during this study?
This study will consist of three study visits over a period of three months. If appropriate, you will be started on apremilast at your first study visit. This is part of your standard of care. The dose of apremilast you will receive will be the normal FDA-approved dose. You will not receive a placebo (sugar) pill. Everyone who participates in the study will be treated with apremilast. The study procedures that will take place at each of the three visits are listed below:
Baseline Visit:
Review inclusion/exclusion criteria Medical history obtained by the study nurse A physical examination by the study doctor Obtain blood and urine samples with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
Study Oversight
Has Oversight DMC:
False
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?: