Sickle Cell DiseaseNCT05494541
Characteristics of Patients With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Crizanlizumab
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 27 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included patients with SCD who initiated crizanlizumab in a real-world setting
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy
This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases.
Read the 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
- Conditions
- Sickle Cell Disease
- Being tested
- Crizanlizumab
- Keywords
- Crizanlizumab,, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizanlizumabOther
Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.
| Study group | Role | What they receive |
|---|---|---|
| Overall cohort | All the patients who met the base inclusion criteria were included in the cohort. Receives: 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. Receives: 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. Receives: Other: Crizanlizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age information was reported.
Measured: Baseline
Number of patients: Gender
Gender information was reported.
Measured: Baseline
Number of patients: Geographic region
The following categories were included:
Northeast, Midwest, South, West
Measured: 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.
Measured: 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.
Measured: Baseline
Number of patients by comorbidity
Number of patients by IQVIA's standard comorbidity list were reported.
Measured: 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.
Measured: Baseline
Number of patients : History of hydroxyurea use
Pre-index treatment history for sickle cell disease was reported.
Measured: Baseline
Number of patients : History of L-glutamine use
Pre-index treatment history for sickle cell disease was reported.
Measured: Baseline
Number of patients : History of Voxelotor use
Pre-index treatment history for sickle cell disease was reported.
Measured: Baseline
Number of patients : SCD genotype
Number of patients with sickle cell disease genotype were reported.
Measured: Baseline
Secondary outcomes (6)
Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Number of hydroxyurea claims
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for L-glutamine while on crizanlizumab therapy
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Number of L-glutamine claims
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for voxelotor while on crizanlizumab therapy
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Number of voxelotor claims
Concomitant SCD treatments after initiating crizanlizumab
Measured: Throughout the follow-up period, approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start30 Aug 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494541
- Sponsor's protocol ID
- CSEG101AUS17
- Status last verified
- Nov 2022
- First submitted
- 8 Aug 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy
- ClinicalTrials.gov ID
- NCT05494541
- Acronym / sponsor ID
- CSEG101AUS17
- Conditions
- Sickle Cell Disease
- Keywords
- Crizanlizumab,, sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | Other: CrizanlizumabAll the patients who met the base inclusion criteria were included in the cohort. |
| Three-month cohort (3m cohort) | – | Other: CrizanlizumabPatients 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. |
| Six-month cohort (6m cohort) | – | Other: CrizanlizumabA 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. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included patients with SCD who initiated crizanlizumab in a real-world setting
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrizanlizumabPatients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort. | Other | Overall cohort, Six-month cohort (6m cohort), Three-month cohort (3m cohort) |
Primary outcome
Age
Time frame: Baseline
Age information was reported.
Number of patients: Gender
Time frame: Baseline
Gender information was reported.
Number of patients: Geographic region
Time frame: Baseline
The following categories were included: Northeast, Midwest, South, West
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.
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.
Number of patients by comorbidity
Time frame: Baseline
Number of patients by IQVIA's standard comorbidity list were reported.
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.
Number of patients : History of hydroxyurea use
Time frame: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients : History of L-glutamine use
Time frame: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients : History of Voxelotor use
Time frame: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients : SCD genotype
Time frame: Baseline
Number of patients with sickle cell disease genotype were reported.
6 secondary outcomes
Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy
Time frame: Throughout the follow-up period, approximately 1.5 years
Number of hydroxyurea claims
Time frame: Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for L-glutamine while on crizanlizumab therapy
Time frame: Throughout the follow-up period, approximately 1.5 years
Number of L-glutamine claims
Time frame: Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for voxelotor while on crizanlizumab therapy
Time frame: Throughout the follow-up period, approximately 1.5 years
Number of voxelotor claims
Time frame: Throughout the follow-up period, approximately 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Results for CSEG101AUS17 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.