Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM)

Study identification

• EU PAS number:
  EUPAS39412
• Study ID:
  47770
• Official title and acronym:
  Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM)
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP). It was based on pharmacovigilance data from the Novartis global safety database on pregnancy cases that were eligible for the study. Although pharmacovigilance data may had been collected from any country in the world where the product was approved, the anonymized patient level data was analyzed at a global level in Switzerland.; Although the study initiated in 2020, the marketing authorizations for Adakveo® were revoked or suspended in several countries, including the EU in Aug-2023, following the study results of CSEG101A2301. As of 30-Jun-2025, there were fewer than 15 pregnancies in the crizanlizumab PRIM study. Given the very low number of patients in the study and the low probability of substantial increase in the sample size, the crizanlizumab PRIM study was terminated prematurely
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:10/07/2020

Actual:10/07/2020

Study start date

Planned:15/11/2020

Actual:15/11/2020

Data analysis start date

Actual:30/06/2025

Date of final study report

Planned:14/11/2031

Actual:30/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CSEG101A2404