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
First published:
21/02/2024
Institution
Chiba University Hospital Chiba, Japan

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
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