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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833022
• Other study ID #: CSEG101AUS16
• Status: Completed
• Start date: July 30, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University Hospital at Cleveland Medical Center	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Beth Israel Hospital	East Hanover	New Jersey
United States	University of Texas (Houston)	Houston	Texas
United States	Montefiore	New York	New York
United States	Washington University of St. Louis	Saint Louis	Missouri
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Cristiana Care	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of patients who discontinued treatment with crizanlizumab		Up to 24 months
Secondary	Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab		Up to 24 months
Secondary	Reasons for early discontinuation of crizanlizumab treatment		Up to 24 months
Secondary	Number of sickle cell disease (SCD)-related hospitalizations		Up to 24 months
Secondary	Number of SCD-related emergency department (ED) visits		Up to 24 months