Determination of treatment efficacy and safety of Apremilast in patients with RAS
The study will be a pilot study using apremilast 30mg orally twice daily, for treatment of RAS in males and females between 18 and 70 years old. Subjects will be recruited from the clinical practice of the Department of Dermatology or Division of Rheumatology at Mayo Clinic Florida. Fifteen males and females with RAS will be enrolled. The study will consist of 3 phases: a screening phase, a 16 week treatment phase and an 8 week posttreatment observational follow-up phase. The screening phase will consist of: obtaining informed consent, demographic information, medical history, inclusion and exclusion criteria, prior and concomitant medication use, adverse events; collecting vital signs and weight; performing complete physical examination and limited physical examination; obtaining hematology, serum chemistry, urinalysis, pregnancy test and providing contraception education. During the 16-week treatment phase, all subjects receive apremilast. All subjects who complete the active treatment phase are to enter the 8-week posttreatment observational follow-up phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Duration of RAS Lesions
The total length of time (duration) subjects experienced RAS lesions. Measured in weeks
Time frame: 24 weeks
Change in Number of RAS Lesions
Number of participants with fewer oral ulcers at Week 24 compared to Baseline
Time frame: baseline, 24 weeks
Duration of the Remission Period Between Ulcer Episodes
The length of time of remission of RAS lesions experienced by the subjects. As measured in months.
Time frame: 24 weeks
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 weeks
Discontinuation of Study Participants
Number of subjects who prematurely discontinue treatment with apremilast due to any adverse event.
Time frame: 24 weeks
Change in Visual Analog Scale Pain Score (VAS) From Baseline to 16 Weeks and Baseline to 24 Weeks.
The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).
Time frame: baseline, 16 weeks, 24 weeks
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