Tildrakizumab Post-Authorisation Safety Study (PASS) in European Psoriasis Registries (M-14745-40)

Study identification

• EU PAS number:
  EUPAS37946
• Study ID:
  37947
• Official title and acronym:
  Tildrakizumab Post-Authorisation Safety Study (PASS) in European Psoriasis Registries (M-14745-40)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Ireland

  Spain

  United Kingdom
• Study description:
  This is a long-term, non-interventional, observational post-authorisation safety study. Using a prospective cohort design, data will primarily be collected in established European registers of patients with psoriasis treated with systemic therapies. ; Data from the registers will be used to identify cohorts of patients with psoriasis who initiate treatment with Tildrakizumab, other biologics or non-biologic systemic therapies for psoriasis. Patients will be followed from cohort entry for up to 8 years to determine the incidence of the outcomes of interest. ; The registers which will provide data on patient demographics, lifestyle factors (e.g. smoking, alcohol use), comorbidities and medications used to treat them, type of psoriasis, physician and patient assessments of the psoriasis, treatment (pre and current) of psoriasis, any adverse events and safety outcomes in pregnant and lactating women.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Oracle Life Sciences

Study timelines

Date when funding contract was signed

Planned:29/05/2019

Actual:29/05/2019

Study start date

Planned:01/09/2020

Actual:15/06/2020

Date of final study report

Planned:01/06/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Almirall S.A.

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)