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

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

ClinicalTrials.gov Identifier: NCT05020873

Novartis Reference Number: CSEG101AIC05

Last Update: Jan 13, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Sickle Cell Disease

Phase

Not Given

Overall status

Recruiting

Start date

Nov 04, 2021

Completion date

May 29, 2025

Gender

All

Age(s)

16 Years - 99 Years (Child, Adult, Older Adult)

Interventions

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.

Eligibility Criteria

Inclusion Criteria:

Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype.
Patients newly initiated on treatment with locally approved crizanlizumab.
Patients aged 16 years or older at crizanlizumab initiation.

Exclusion Criteria:

Patients who did not provide informed consent.
Patients who received a stem cell transplant at time of enrollment.
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.
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.