Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype. 2. Patients newly initiated on treatment with locally approved crizanlizumab. 3. Patients aged 16 years or older at crizanlizumab initiation.
Exclusion criteria
Exclusion criteria: 1. Patients who did not provide informed consent. 2. Patients who received a stem cell transplant at the time of enrollment. 3. Patients who participated in or participating in a clinical trial at the time of enrollment or in the 12 months prior to starting commercial crizanlizumab. 4. According to the investigatorâ??s opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the annualized rate of VOCs treated in a medical facility among patients with SCD receiving crizanlizumab in a real-world setting.Timepoint: The outcome will be assessed at the given time points : Baseline, 3, 6, 12, 18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to assess the following 1.Opioid use for pain management of VOCs 2.Home-managed VOCs (using the Sickle Cell Pain Diary â?? Self Report [SCPD-S]) 3.Clinical laboratory parameters 4.Acute and chronic complications 5.Quality of life (via the SCPD-S) 6.SCD-related healthcare resource utilization (HRU) 7.SCD-related treatment patterns Note home managed VOC is defined as VOC that is being managed at home by the patient.Timepoint: 1. The type, dose, duration of use of opioids for pain management of VOCs within the medical facility and at home. The utilization of opioids at baseline will be collected for the previous year from patient charts. 2. The number, type, duration and outcome of VOCs leading to hospitalization. 3. The number (and annualized rate for Month 12 and Month 24 only) of home managed VOCs as captured in the medical records and as per data from the SCPD-S. | — |
Countries
Bahrain, Egypt, India, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates
Contacts
Public ContactDr Manish Mistry
Novartis Healthcare Private Limited
Outcome results
None listed