A Retrospective Cohort Study for Estimating Incidence Rates of Infusion Site Events for ABBV-951 for the Treatment of Advanced Parkinson's Disease

Study identification

• EU PAS number:
  EUPAS1000000050
• Study ID:
  1000000050
• Official title and acronym:
  A Retrospective Cohort Study for Estimating Incidence Rates of Infusion Site Events for ABBV-951 for the Treatment of Advanced Parkinson's Disease
• DARWIN EU® study:
  No
• Study countries:
  Finland

  Portugal
• Study description:
  The overall aim of this study is to evaluate the effectiveness of additional risk minimization measures (aRMM) by estimating the incidence rates of infusion site events (i.e., first infusion site infections and/or serious infusion site reactions) in Parkinson disease (PD) patients exposed to ABBV-951 in real-world clinical practice, using data sources from Finland and Portugal. ; The frequency of infusion site events observed in this real-world study will be interpreted in context of the predefined reference value which is the frequency of the infusion site events reported in the AbbVie clinical trial.; ; The following primary and secondary objectives will be investigated among patients with advanced PD following initiation of treatment with ABBV-951:; ; Primary objective:; • To quantify the incidence rate of first infusion site events (first infusion site infection OR first serious infusion site reactions); ; Secondary objectives:; • To quantify the incidence rate of first infusion site infection; • To quantify the incidence rate of first serious infusion site reaction
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

AbbVie

Study timelines

Date when funding contract was signed

Planned:01/11/2022

Actual:03/11/2022

Study start date

Planned:01/07/2027

Data analysis start date

Planned:01/04/2028

Date of final study report

Planned:31/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie Inc.

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)