Herpes zoster and other opportunistic infections in patients with inflammatory bowel disease in Norway – associations with immunosuppressive treatment (NOZOIBD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44561
• EU PAS number:
  EUPAS36045
• Study ID:
  44561
• Official title and acronym:
  Herpes zoster and other opportunistic infections in patients with inflammatory bowel disease in Norway – associations with immunosuppressive treatment (NOZOIBD)
• DARWIN EU® study:
  No
• Study countries:
  Norway
• Study description:
  Due to extenuating business circumstances based on availability of data and resources Pfizer will not be pursuing this study. Study is officially cancelled on 30 November 2021. Patients with inflammatory bowel disease (IBD), i.e. ulcerative colitis or Crohn’s disease are treated with immunosuppressive drugs that increases their risk of infections, including herpes zoster (HZ) and other opportunistic infections (OI). This non-interventional retrospective observational study aims to quantify rates of HZ and other OI, including the association with immunosuppressive treatment, in Norwegian IBD patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 12/01/2020

Actual: 24/01/2020

Study start date

Planned: 01/02/2022

Actual: 30/11/2021

Date of final study report

Planned: 01/06/2023

Actual: 30/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921367_PROTOCOL and APPROVAL_V1.0_04MAY2020

Updated protocol

A3921367_Non-Interventional Study Protocol Amendment 1_V2.0_30MAR2021

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable