Clinical trial NCT05494541: Characteristics of Patients With Sickle Cell Disease
Official title: Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Crizanlizumab,
sickle cell disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 540
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients with SCD who initiated crizanlizumab in a real-world setting

Brief summary: This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases.

Detailed description: Patients with a diagnosis of SCD between November 1, 2018 and April 30, 2021 were identified. Among these patients, those who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort. The indexing timeframe allowed for a 1-year lookback period and a minimum of 3 months (3m cohort) of follow-up. A subset of the 3m cohort with 6-months of available (6m cohort) follow-up was performed. The index date was the date of the first crizanlizumab administration.

Study period: 01 November 2018 - 30 April 2021 Index period: 01 November 2019 - 31 January 2021 Index date: Date of the first claim for administration of crizanlizumab in the index period

Eligibility criteria: Inclusion Criteria:

* At least 1 claim in IQVIA Patient Centric Medical Claims Database (Dx) with SCD diagnosis (ICD-10 D57.xx, except D57.3) within the study period;
* At least 1 claim for administration of crizanlizumab within the index period. Index date was the date of first administration;
* At least 1 claim with HCPCs for crizanlizumab (J0791) OR with at least one claim for an unspecified biologic (J3590) on the same day as a claim for SCD (ICD-10 D57.xx, except D57.3) OR with at least one claim with HCPCs C9053;
* At least 16 years of age on the index date;
* Linkage to the IQVIA Longitudinal Prescription Database (LRx) within the study period;
* Stability and eligibility in Dx during the 12 months prior to the index date;
* Stability and eligibility in LRx during the 12 months prior to the index date

Exclusion Criteria:

* None

Primary outcomes:
measure: Age
timeFrame: Baseline
measure: Number of patients: Gender
timeFrame: Baseline
measure: Number of patients: Geographic region
timeFrame: Baseline
measure: Number of patients: Insurance type
timeFrame: Baseline
measure: Number of patients by Charlson Comorbidity Index (CCI) score category
timeFrame: Baseline
measure: Number of patients by comorbidity
timeFrame: Baseline
measure: Number of patients with history of additional SCD-related comorbidities associated with organ damage
timeFrame: Baseline
measure: Number of patients : History of hydroxyurea use
timeFrame: Baseline
measure: Number of patients : History of L-glutamine use
timeFrame: Baseline
measure: Number of patients : History of Voxelotor use
timeFrame: Baseline
measure: Number of patients : SCD genotype
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy
timeFrame: Throughout the follow-up period, approximately 1.5 years
measure: Number of hydroxyurea claims
timeFrame: Throughout the follow-up period, approximately 1.5 years
measure: Proportion of patients with claims for L-glutamine while on crizanlizumab therapy
timeFrame: Throughout the follow-up period, approximately 1.5 years
measure: Number of L-glutamine claims
timeFrame: Throughout the follow-up period, approximately 1.5 years
measure: Proportion of patients with claims for voxelotor while on crizanlizumab therapy
timeFrame: Throughout the follow-up period, approximately 1.5 years
measure: Number of voxelotor claims
timeFrame: Throughout the follow-up period, approximately 1.5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: