Apremilast for RAS

Phase 4

Completed

Brief Summary: Determination of treatment efficacy and safety of Apremilast in patients with RAS

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Single Arm	Apremilast 30mg	Apremilast 30mg orally twice daily for 16 weeks, sixteen weeks on active study. Post treatment follow-up period of 8 weeks, in the Treatment of Subjects with Severe Recurrent Aphthous Stomatitis (RAS)

Primary Outcome Measures

Name	Time	Method
Duration of RAS Lesions	24 weeks	The total length of time (duration) subjects experienced RAS lesions. Measured in weeks
Change in Number of RAS Lesions	baseline, 24 weeks	Number of participants with fewer oral ulcers at Week 24 compared to Baseline
Duration of the Remission Period Between Ulcer Episodes	24 weeks	The length of time of remission of RAS lesions experienced by the subjects. As measured in months.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	24 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Discontinuation of Study Participants	24 weeks	Number of subjects who prematurely discontinue treatment with apremilast due to any adverse event.
Change in Visual Analog Scale Pain Score (VAS) From Baseline to 16 Weeks and Baseline to 24 Weeks.	baseline, 16 weeks, 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).