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: May 03, 2022

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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.

Study Locations

Kuwait
Novartis Investigative Site
Recruiting
Al Ahmadi, 52700
-
Kuwait
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Novartis Investigative Site
Recruiting
Doha, 305
-
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Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]