Observational, real-world study of INFLECTRA in patients with inflammatory bowel disease (IBD) in the United States and Canada (ONWARD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39469
• EU PAS number:
  EUPAS22444
• Study ID:
  39469
• Official title and acronym:
  Observational, real-world study of INFLECTRA in patients with inflammatory bowel disease (IBD) in the United States and Canada (ONWARD)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  To describe drug use patterns, treatment adherence and associated costs in adult UC and CD cohorts treated with INFLECTRA in a real-world setting
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/02/2017

Actual: 23/02/2018

Study start date

Planned: 19/02/2018

Actual: 23/02/2018

Date of final study report

Planned: 31/10/2019

Actual: 28/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C1231006 PROTOCOL_Amendment 2_Pfizer_Inflectra_ONWARD_Study_25Jan2018 V3

Updated protocol

C1231006 AMENDMENT 3 PROTOCOL VERSION 3_09SEP2020_Redacted

Regulatory

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