Characteristics of Patients With Sickle Cell Disease

NCT05494541 | Completed

• 1 other identifier: CSEG101AUS17
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

Crizanlizumab,; sickle cell disease

Outcome Measures

Primary Outcomes (11)

• Age

  Age information was reported.

  Baseline

• Number of patients: Gender

  Gender information was reported.

  Baseline

• Number of patients: Geographic region

  The following categories were included: Northeast, Midwest, South, West

  Baseline

• 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

• 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

• Number of patients by comorbidity

  Number of patients by IQVIA's standard comorbidity list were reported.

  Baseline

• 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

• Number of patients : History of hydroxyurea use

  Pre-index treatment history for sickle cell disease was reported.

  Baseline

• Number of patients : History of L-glutamine use

  Pre-index treatment history for sickle cell disease was reported.

  Baseline

• Number of patients : History of Voxelotor use

  Pre-index treatment history for sickle cell disease was reported.

  Baseline

• Number of patients : SCD genotype

  Number of patients with sickle cell disease genotype were reported.

  Baseline

Secondary Outcomes (6)

• Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy

  Throughout the follow-up period, approximately 1.5 years

• Number of hydroxyurea claims

  Throughout the follow-up period, approximately 1.5 years

• Proportion of patients with claims for L-glutamine while on crizanlizumab therapy

  Throughout the follow-up period, approximately 1.5 years

• Number of L-glutamine claims

  Throughout the follow-up period, approximately 1.5 years

• Proportion of patients with claims for voxelotor while on crizanlizumab therapy

  Throughout the follow-up period, approximately 1.5 years

Study Arms (3)

Overall cohort

All the patients who met the base inclusion criteria were included in the cohort.

Other: Crizanlizumab

Three-month cohort (3m cohort)

Patients with stability and eligibility in IQVIA Patient Centric Medical Claims Database (Dx) and stability and eligibility in IQVIA Longitudinal Prescription Database (LRx) during the 3 months following the index date were included in the cohort.

Other: Crizanlizumab

Six-month cohort (6m cohort)

A subset of patients from the 3m cohort with stability and eligibility in Dx and stability and eligibility in LRx during the 6 months following the index date were included in this cohort.

Other: Crizanlizumab

Interventions

Crizanlizumab OTHER

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

Overall cohort; Six-month cohort (6m cohort); Three-month cohort (3m cohort)

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients with SCD who initiated crizanlizumab in a real-world setting

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CSEG101AUS17 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

crizanlizumab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 30, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)