Characteristics of Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494541
• Other study ID #: CSEG101AUS17
• Status: Completed
• Start date: August 30, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Crizanlizumab
Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age information was reported.	Baseline
Primary	Number of patients: Gender	Gender information was reported.	Baseline
Primary	Number of patients: Geographic region	The following categories were included: Northeast, Midwest, South, West	Baseline
Primary	Number of patients: Insurance type	When multiple payer types were observed, the following hierarchy was used: Medicare, Commercial, Medicaid, Cash, Unspecifed.; When commercially-managed Medicaid was observed, the Medicaid designation was assigned.	Baseline
Primary	Number of patients by Charlson Comorbidity Index (CCI) score category	Severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores =5.	Baseline
Primary	Number of patients by comorbidity	Number of patients by IQVIA's standard comorbidity list were reported.	Baseline
Primary	Number of patients with history of additional SCD-related comorbidities associated with organ damage	Number of patients with history of additional SCD-related comorbidities associated with organ damage were reported.	Baseline
Primary	Number of patients : History of hydroxyurea use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Primary	Number of patients : History of L-glutamine use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Primary	Number of patients : History of Voxelotor use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Primary	Number of patients : SCD genotype	Number of patients with sickle cell disease genotype were reported.	Baseline
Secondary	Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Secondary	Number of hydroxyurea claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Secondary	Proportion of patients with claims for L-glutamine while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Secondary	Number of L-glutamine claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Secondary	Proportion of patients with claims for voxelotor while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Secondary	Number of voxelotor claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years

External Links

•   Results for CSEG101AUS17 from the Novartis Clinical Trials Website