Real World Patient Characteristics and Treatment Patterns From Crizanlizumab Use: Preliminary Analysis From Select Sickle Cell Centers

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT06662825
• Lead Sponsor: Novartis

Brief Summary

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with patients who had initiated crizanlizumab between 2019 and 2022.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-12-13
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Age at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Gender at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Race	Day 1 of Year 2
Ethnicity	Day 1 of Year 2
Insurance Type at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Number of Patients Categorized by Comorbidity	Baseline
Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab	Baseline
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy	Baseline	Red blood cell transfusion therapy time intervals: * 0-3 months; * 3-6 months; * 6-12 months; * \>12 months; * Unknown
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy	Up to 1 year	Red blood cell transfusion therapy time intervals: * 0-3 months; * 3-6 months; * 6-12 months; * \>12 months; * Unknown
Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion.; DMTs included: * Any SCD specific therapy; * Hydroxyurea; * Voxelotor; * L-Glutamine; * Other

Secondary Outcome Measures

Name	Time	Method
Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment	1 year
Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion.
Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion.

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States