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

Novartis

Status: Terminated

Conditions: Sickle Cell Disease

Treatments: Other: Crizanlizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05020873

CSEG101AIC05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 1 patient group

Crizanlizumab

Description:

Patients initiated on treatment with commercially available crizanlizumab

Treatment:

Other: Crizanlizumab