Treatment With Apremilast in Patients With Psoriatic Arthritis
NCT02558361 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2016-10-21
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.
Conditions
Interventions
- DRUG
-
Treatment with Apremilast
Standard dosing with apremilast (Otezla) will be used. \[30mg po BID after initial titration\]
Sponsors & Collaborators
-
University of South Florida
lead OTHER
Principal Investigators
-
John D Carter, MD · University of South Florida Morsani College of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
Countries
- United States
Study Locations
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