A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS) (ESPRIT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48814
• EU PAS number:
  EUPAS30560
• Study ID:
  48814
• Official title and acronym:
  A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS) (ESPRIT)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  Denmark

  France

  Germany

  Greece

  Ireland

  Netherlands

  Puerto Rico

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 01/02/2008

Study start date

Actual: 26/09/2008

Date of final study report

Planned: 23/10/2023

Actual: 16/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p10023-protocol-amendment3_Redacted_13Aug2019

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

P10-023