Post-marketing Surveillance (PMS) on long term use of Ofev Capsules in Systemic Scleroderma associated Interstitial Lung Disease (SSc-ILD) in Japan (PMS for Ofev (SSc-ILD))

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45827
• EU PAS number:
  EUPAS32905
• Study ID:
  45827
• Official title and acronym:
  Post-marketing Surveillance (PMS) on long term use of Ofev Capsules in Systemic Scleroderma associated Interstitial Lung Disease (SSc-ILD) in Japan (PMS for Ofev (SSc-ILD))
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective is to confirm the incidence of adverse drug reactions to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 19/03/2020

Actual: 19/03/2020

Study start date

Planned: 01/04/2020

Actual: 27/05/2020

Data analysis start date

Planned: 30/06/2026

Date of final study report

Planned: 31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co.,Ltd.

Regulatory

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