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

April 17, 2023 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Cristiana Care
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University of St. Louis
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Beth Israel Hospital
    • New York
      • New York, New York, United States, 10461
        • Montefiore
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital at Cleveland Medical Center
      • Columbus, Ohio, United States, 43203
        • Ohio State University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas (Houston)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) prior to treatment with crizanlizumab
Time Frame: Up to 12 months
Up to 12 months
Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) during treatment with crizanlizumab
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who discontinued treatment with crizanlizumab
Time Frame: Up to 24 months
Up to 24 months
Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab
Time Frame: Up to 24 months
Up to 24 months
Reasons for early discontinuation of crizanlizumab treatment
Time Frame: Up to 24 months
Up to 24 months
Number of sickle cell disease (SCD)-related hospitalizations
Time Frame: Up to 24 months
Up to 24 months
Number of SCD-related emergency department (ED) visits
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Actual)

April 18, 2022

Study Completion (Actual)

April 18, 2022

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSEG101AUS16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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