Post Authorization Safety Study (PASS) to Investigate Relevant Safety Outcomes among Patients Treated with Benepali for Psoriasis within the British Association of Dermatologists Biologic Interventions Register (BADBIR)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001086
• Study ID:
  1000001086
• Official title and acronym:
  Post Authorization Safety Study (PASS) to Investigate Relevant Safety Outcomes among Patients Treated with Benepali for Psoriasis within the British Association of Dermatologists Biologic Interventions Register (BADBIR)
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  United Kingdom
• Study description:
  To assess the long-term safety and the risk of serious adverse events in psoriasis patients treated with Benepali (etanercept) compared to conventional systemic therapies with comparable disease severity, using data from the BADBIR registry.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of Manchester

United Kingdom

Study timelines

Date when funding contract was signed

Planned:01/05/2016

Actual:01/05/2016

Study start date

Planned:01/05/2016

Actual:01/05/2016

Date of final study report

Planned:21/07/2026

Actual:21/07/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Samsung Bioepis NL B.V.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)