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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37753
• EU PAS number:
  EUPAS36072
• Study ID:
  37753
• Official title and acronym:
  OTEZLA® tablets General use-results survey (BCT) (20200279)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This survey will be conducted at approximately 40 sites in Japan which have previously introduced OTEZLA®. Around 100 patients who have oral ulcers due to Behçet’s Disease that also had an inadequate response to topical treatment are planned to be included. ; The planned survey period is 4 years after survey initiation. ; Information will be collected to evaluate the safety of OTEZLA® in a clinical setting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Chiba University Hospital Chiba, Japan

Study timelines

Date when funding contract was signed

Planned: 06/07/2020

Actual: 06/07/2020

Study start date

Planned: 20/10/2020

Actual: 22/10/2020

Data analysis start date

Planned: 04/03/2025

Date of final study report

Planned: 31/05/2025

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: 20200279