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
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 institutions and networks

Institutions

AbbVie

Contact details

Mickael Arnaud

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
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)