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

NCT06662825 | Completed

• 1 other identifier: CSEG101AUS20
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (10)

• Age at Index Date

  Index date was defined as the date of the first crizanlizumab infusion

  Day 1 of Year 2

• Gender at Index Date

  Index date was defined as the date of the first crizanlizumab infusion

  Day 1 of Year 2

• Race

  Day 1 of Year 2

• Ethnicity

  Day 1 of Year 2

• Insurance Type at Index Date

  Index date was defined as the date of the first crizanlizumab infusion

  Day 1 of Year 2

• 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

  Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

  Baseline

• Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy

  Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

  Up to 1 year

• Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date

  Index date was defined as the date of the first crizanlizumab infusion. DMTs included: * Any SCD specific therapy * Hydroxyurea * Voxelotor * L-Glutamine * Other

  Up to 2 years

Secondary Outcomes (3)

• 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

• Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date

  Up to 2 years

Study Arms (1)

Crizanlizumab Cohort

Patients with sickle cell disease (SCD) who had received at least one dose of crizanlizumab between 2019 and 2022.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Any patient with a diagnosis of SCD based on high performance liquid chromatography (HPLC) or hemoglobin electrophoresis at treating institution.
• Treatment order for crizanlizumab; Index date was defined as the date for the first crizanlizumab treatment.
• At least 12 months of available electronic medical record (EMR) data pre-index date (baseline).
• Patients must have received at least one dose of crizanlizumab.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: December 13, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)