Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM) (Adakveo (crizanlizumab) PRIM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47770
• EU PAS number:
  EUPAS39412
• Study ID:
  47770
• Official title and acronym:
  Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM) (Adakveo (crizanlizumab) PRIM)
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  This is 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 is based on pharmacovigilance data from the Novartis global safety database on pregnancy cases that are eligible for the study. Although pharmacovigilance data may be collected from any country in the world where the product is approved, the anonymized patient level data will be analyzed at a global level in Switzerland.
• Study status:
  Ongoing

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

Date of final study report

Planned: 15/05/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

Protocol_SEG101 PRIM_10July2020_clean_Redacted

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