Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India

N/ATerminatedNCT05020873

Novartis Pharmaceuticals44 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sickle Cell Disease

Interventions

CrizanlizumabOTHER

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 99 Years

Medical Language ↔ Plain English

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: 1. Patients who did not provide informed consent. 2. Patients who received a stem cell transplant at time of enrollment. 3. Patients who participated in or are participating in a clinical trial at time of enrollment or in the 12 months prior to starting commercial crizanlizumab. 4. According to the investigator'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.

Locations (5)

Novartis Investigative Site

Manama, Bahrain

Novartis Investigative Site

Al Ahmadi, Kuwait

Novartis Investigative Site

Doha, Qatar

Novartis Investigative Site

Dammam, Saudi Arabia

Novartis Investigative Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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