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.
Interventions
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
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]