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Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05833022
Collaborator
(none)
297
Enrollment
11
Locations
8.6
Actual Duration (Months)
27
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with at least five patients who initiated crizanlizumab. Patients who were prescribed crizanlizumab were included in the cohort.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    297 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers
    Actual Study Start Date :
    Jul 30, 2021
    Actual Primary Completion Date :
    Apr 18, 2022
    Actual Study Completion Date :
    Apr 18, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) prior to treatment with crizanlizumab [Up to 12 months]

    2. Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) during treatment with crizanlizumab [Up to 12 months]

    Secondary Outcome Measures

    1. Number of patients who discontinued treatment with crizanlizumab [Up to 24 months]

    2. Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab [Up to 24 months]

    3. Reasons for early discontinuation of crizanlizumab treatment [Up to 24 months]

    4. Number of sickle cell disease (SCD)-related hospitalizations [Up to 24 months]

    5. Number of SCD-related emergency department (ED) visits [Up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:

    • Any patient with 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

    • For inclusion in pre/post analysis of effectiveness, patients must have received at least 6 doses of medication. The rates could be annualized if total post-index time was <12 months.

    Exclusion criteria:

    None specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Birmingham Alabama United States 35233
    2 Cristiana Care Wilmington Delaware United States 19801
    3 All Children's Hospital Saint Petersburg Florida United States 33701
    4 Johns Hopkins University Baltimore Maryland United States 21205
    5 Washington University of St. Louis Saint Louis Missouri United States 63110
    6 Beth Israel Hospital East Hanover New Jersey United States 07936
    7 Montefiore New York New York United States 10461
    8 University of North Carolina Chapel Hill North Carolina United States 27514
    9 University Hospital at Cleveland Medical Center Cleveland Ohio United States 44106
    10 Ohio State University Columbus Ohio United States 43203
    11 University of Texas (Houston) Houston Texas United States 77030

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05833022
    Other Study ID Numbers:
    • CSEG101AUS16
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Apr 27, 2023