OTEZLA® tablets General use-results survey (BCT) (20200279)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OTEZLA
• Study drug International non-proprietary name (INN) or common name:
  APREMILAST
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA32) apremilast

  apremilast
• Medical condition to be studied:
  Behcet's syndrome
• Additional medical condition(s):
  Subjects with oral ulcers due to Behçet’s Disease

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The objective of this survey is to evaluate the safety of OTEZLA® tablets in actual clinical settings of use in OTEZLA-naïve subjects with oral ulcers due to Behçet’s Disease who have had an inadequate response to topical treatment.
• Outcomes:
  Incidence of Adverse Drug Reactions, especially incidence of gastrointestinal disorders.
• Data analysis plan:
  Analyses are descriptive in nature, including confidence intervals. ; Due to the nature of the observational study, no confirmatory statistical testing is foreseen in this study. ; Subgroup analyses are also performed if sample size allows.