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sponsor decision
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This is a multicenter, prospective, single-arm observational non-interventional study (NIS), which will be conducted in various countries in the Middle East and India.
The study is designed to collect information on the utilization and effectiveness of crizanlizumab treatment in SCD patients under routine clinical practice conditions, to which the physician has made an independent decision to prescribe crizanlizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizanlizumab | Patients initiated on treatment with commercially available crizanlizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizanlizumab | Other | Prospective observational study. There is no treatment allocation. Patients administered crizanlizumab, that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of healthcare visit and home-managed (VOCs) requiring a medical facility visit | The annualized rate of VOCs is defined as the total number of pain crises for a patient occurring from the date of initial infusion with crizanlizumab (commercially available) to the last contact date of the study end date × 365 divided by the number of days during that same time period. This calculation accounts for early dropouts or lost to follow-up by extrapolating the VOC rate of every patient to 1 year. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. | Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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patients with SCD initiated on treatment with commercially available crizanlizumab at sites
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Manama | 20525 | Bahrain | |||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000614139 | crizanlizumab |
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| Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. |
Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected |
| Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home. | Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Number of healthcare visit and home-managed (VOCs) leading to hospitalization | Number of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Type of healthcare visit and home-managed (VOCs) leading to hospitalization | Type of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Duration of healthcare visit and home-managed (VOCs) leading to hospitalization | Duration of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization | Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected. | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S. | Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected. SCPD-S: Sickle Cell Pain Diary - Self Report | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S. | Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected. SCPD-S: Sickle Cell Pain Diary - Self Report | month 12 and month 24 |
| Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit | Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Percentage of patients with acute and chronic complications/ end organ damage related to SCD | Percentage of patients with acute and chronic complications/ end organ damage related to SCD to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Frequency of patients on blood transfusions | Frequency of patients on blood transfusions to be collected. Blood transfusions: simple/ exchange/ chronic/ episodic | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Frequency of patients with SCD-related Healthcare Resource Utilization (HRU) | Frequency of patients with SCD-related Healthcare Resource Utilization (HRU) to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Number of patients with clinical laboratory parameters abnormalities | Number of patients with clinical laboratory parameters abnormalities to be collected | Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Al Ahmadi |
| 52700 |
| Kuwait |
| Novartis Investigative Site | Doha | 305 | Qatar |
| Novartis Investigative Site | Dammam | 32263 | Saudi Arabia |
| Novartis Investigative Site | Jizan | 82943 | Saudi Arabia |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |