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OpenTrials
Completed

NCT Number: NCT05494541

Characteristics of Patients With Sickle Cell Disease

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

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Key information

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crizanlizumab

Other

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

Primary outcomes

  1. Age

    Time frame: Baseline

    Age information was reported.

  2. Number of patients: Gender

    Time frame: Baseline

    Gender information was reported.

  3. Number of patients: Geographic region

    Time frame: Baseline

    The following categories were included:

    Northeast, Midwest, South, West

  4. Number of patients: Insurance type

    Time frame: Baseline

    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.

  5. Number of patients by Charlson Comorbidity Index (CCI) score category

    Time frame: Baseline

    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.

  6. Number of patients by comorbidity

    Time frame: Baseline

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

  7. Number of patients with history of additional SCD-related comorbidities associated with organ damage

    Time frame: Baseline

    Number of patients with history of additional SCD-related comorbidities associated with organ damage were reported.

  8. Number of patients : History of hydroxyurea use

    Time frame: Baseline

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

  9. Number of patients : History of L-glutamine use

    Time frame: Baseline

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

  10. Number of patients : History of Voxelotor use

    Time frame: Baseline

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

  11. Number of patients : SCD genotype

    Time frame: Baseline

    Number of patients with sickle cell disease genotype were reported.

Secondary outcomes

  1. Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

  2. Number of hydroxyurea claims

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

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

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

  4. Number of L-glutamine claims

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

  5. Proportion of patients with claims for voxelotor while on crizanlizumab therapy

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

  6. Number of voxelotor claims

    Time frame: Throughout the follow-up period, approximately 1.5 years

    Concomitant SCD treatments after initiating crizanlizumab

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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