OTEZLA® Tablets Drug Use-Results Survey (CC-10004-PSOR-018)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Name of medicine:
  OTEZLA
• Medical condition to be studied:
  Psoriasis

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  The study population comprised of patients with psoriasis vulgaris and psoriatic arthritis received treatment with OTEZLA® tablets in a routine clinical practice in Japan.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with psoriasis
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main objective of this study is to evaluate the safety and efficacy of OTEZLA® tablets in patients with psoriasis vulgaris and patients with psoriatic arthritis in actual clinical settings.
• Outcomes:
  Incidence of Adverse Drug Reactions, especially incidence of serious infections, gastrointestinal disorders, serious hypersensitivity, weight decrease, vasculitis, malignancies, depression and suicidal ideation.
• 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.

Documents

Study results

20200068 ORSR Abstract