An observational study in Sickle Cell Disease, sponsored by Novartis Pharmaceuticals. Terminated at 5 sites in 4 countries. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's enrollment of 44 is below the median of 100 across 296 observational studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients with SCD initiated on treatment with commercially available crizanlizumab at sites
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients initiated on treatment with commercially available crizanlizumab
Other: Crizanlizumab
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.
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.
Time frame: 12 months
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
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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