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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36685
• EU PAS number:
  EUPAS36684
• Study ID:
  36685
• Official title and acronym:
  OTEZLA® Tablets Drug Use-Results Survey (CC-10004-PSOR-018)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This survey will be conducted at approximately 150 sites in Japan. Around 1000 patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA® tablets are planned to be included. The planned survey period is 4 years from 6 months after launch. The key survey items include serious infections, gastrointestinal disorders, serious hypersensitivity, weight decrease, vasculitis, malignancies, depression and suicidal ideation. Information will be collected to evaluate the safety and efficacy of OTEZLA® in actual clinical settings.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/07/2017

Actual: 04/08/2017

Study start date

Planned: 01/09/2017

Actual: 05/09/2017

Data analysis start date

Planned: 30/11/2024

Actual: 11/12/2022

Date of final study report

Planned: 31/05/2025

Actual: 21/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

Protocol number-CC-10004-PSOR-018