A longitudinal study of 4 cohorts of patients with psoriasis and psoriatic arthritis: one treated with Otezla (apremilast), one with an injectable comparator drug, one with an oral comparator drug and one with an oral and an injectable comparator drug (Otezla-CPRD-001)

Study identification

• EU PAS number:
  EUPAS11891
• Study ID:
  39206
• Official title and acronym:
  A longitudinal study of 4 cohorts of patients with psoriasis and psoriatic arthritis: one treated with Otezla (apremilast), one with an injectable comparator drug, one with an oral comparator drug and one with an oral and an injectable comparator drug (Otezla-CPRD-001)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The study is designed to provide long-term surveillance of as per the protocol defined adverse events of special interest (AESIs) in patients with psoriasis and/or psoriatic arthritis exposed to Otezla (apremilast) by calculating rates of events and comparing the rates with those in Otezla non-exposed populations.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 19/11/2015

Study start date

Planned: 13/02/2015

Actual: 13/02/2015

Data analysis start date

Planned: 01/12/2016

Actual: 01/12/2016

Date of interim report, if expected

Planned: 01/08/2018

Actual: 17/10/2018

Date of final study report

Planned: 13/08/2020

Actual: 26/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

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)