Clinical trial NCT06662825: Real World Patient Characteristics and Treatment Patterns From Crizanlizumab Use: Preliminary Analysis From Select Sickle Cell Centers
Official title: SEG-2022-01 Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 376
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: Inclusion criteria

* 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.
* For inclusion in pre/post analysis of effectiveness, patients must have received crizanlizumab for at least 12 months.

Exclusion criteria None identified.

Primary outcomes:
measure: Age at Index Date
timeFrame: Day 1 of Year 2
measure: Gender at Index Date
timeFrame: Day 1 of Year 2
measure: Race
timeFrame: Day 1 of Year 2
measure: Ethnicity
timeFrame: Day 1 of Year 2
measure: Insurance Type at Index Date
timeFrame: Day 1 of Year 2
measure: Number of Patients Categorized by Comorbidity
timeFrame: Baseline
measure: Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab
timeFrame: Baseline
measure: Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy
timeFrame: Baseline
measure: Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy
timeFrame: Up to 1 year
measure: Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment
timeFrame: 1 year
measure: Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date
timeFrame: Up to 2 years
measure: Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: