Crizanlizumab Pregnancy Outcomes Intensive Monitoring

Novartis Pharmaceuticals13 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sickle Cell Disease

Eligibility

Sex: ALLMin age: 16 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: All prospective and retrospective pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database were eligible for the PRIM program. Exclusion Criteria: Cases with the following exclusion criteria were excluded from the crizanlizumab PRIM study: * Patients who upon initial case report refuse to be contacted to obtain any FU information. In such cases necessary information using PRIM follow-up checklists cannot be obtained. * Indirect cases (reported by someone other than the patient or the healthcare provider (HCP)) for which the reporter refuses to provide FU information and the patient or HCP cannot be identified based on the information provided. * Pregnancies of female partners of male patients taking crizanlizumab. Such cases were to be processed as per Manual for Argus Processing (MAP). * Cases lacking reporter contact details (e.g., cases from social media) or incomplete cases in which data was missing to allow classification of pregnancy or infant outcomes.

Locations (1)

Novartis Investigative SIte

Basel, Switzerland

Outcomes

Primary Outcomes

Proportion of pregnancies resulting in fetal loss

proportion of pregnancies resulting in fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), among pregnant women exposed to crizanlizumab within 105 days prior to LMP or at any time during pregnancy.

Time frame: Duration of study, up to 56 months

Secondary Outcomes

Proportion of major congenital malformations among pregnancies exposed to crizanlizumab

proportion of major congenital malformations among pregnancies exposed to crizanlizumab up to 105 days before LMP and during pregnancy reported to Novartis amongst (i) live births and (ii) live births plus still births plus termination of pregnancy for fetal anomaly (TOPFA).

Time frame: Duration of study, up to 56 months

Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab

proportion of overall congenital malformations among pregnancies exposed to crizanlizumab up to 105 days before LMP and during pregnancy reported to Novartis with the outcome of total live births, and live birth plus still births and TOPFA.

Time frame: Duration of study, up to 56 months

Data from ClinicalTrials.gov

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