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

• PURI:
  https://redirect.ema.europa.eu/resource/1000000050
• 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

  France
• Study description:
  The overall aim of this study is to evaluate the effectiveness of additional risk minimization measures (aRMM) by estimating incidence rates of infusion site events (i.e., 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 France. 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 objectives will be investigated among patients with advanced PD following initiation of treatment with ABBV-951: ; ; • To quantify the incidence rate of first infusion site events (first infusion site infection OR first serious infusion site reactions); • 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 institution and networks

Institutions

Global Database Studies (GloDaSt), IQVIA

Czechia

Finland

Germany

Slovakia

Spain

AbbVie

Study timelines

Date when funding contract was signed

Planned: 01/11/2022

Actual: 03/11/2022

Study start date

Planned: 01/06/2025

Data analysis start date

Planned: 01/09/2027

Date of final study report

Planned: 01/03/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie Inc.

Study protocol

Initial protocol

P24151-Protocol v1.0_Redacted.pdf

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)