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

January 24, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain, 20525
        • Novartis Investigative Site
  • Kuwait
      • Al Ahmadi, Kuwait, 52700
        • Novartis Investigative Site
  • Qatar
      • Doha, Qatar, 305
        • Novartis Investigative Site
  • Saudi Arabia
      • Dammam, Saudi Arabia, 32263
        • Novartis Investigative Site
      • Jazan, Saudi Arabia, 82943
        • Novartis Investigative Site
  • United Arab Emirates
      • Al Ain Abu Dhabi, United Arab Emirates
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with SCD initiated on treatment with commercially available crizanlizumab at sites

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crizanlizumab
Patients initiated on treatment with commercially available crizanlizumab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of healthcare visit and home-managed (VOCs) requiring a medical facility visit
Time Frame: 12 months

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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home to be collected
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.
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 to be collected
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.
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 to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Number of healthcare visit and home-managed (VOCs) leading to hospitalization
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 to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Type of healthcare visit and home-managed (VOCs) leading to hospitalization
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Type of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Duration of healthcare visit and home-managed (VOCs) leading to hospitalization
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Duration of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization to be collected.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S.
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected.

SCPD-S: Sickle Cell Pain Diary - Self Report
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S.
Time Frame: month 12 and month 24

Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S to be collected.

SCPD-S: Sickle Cell Pain Diary - Self Report
month 12 and month 24
Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Percentage of patients with acute and chronic complications/ end organ damage related to SCD
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Percentage of patients with acute and chronic complications/ end organ damage related to SCD to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Frequency of patients on blood transfusions
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Frequency of patients on blood transfusions to be collected. Blood transfusions: simple/ exchange/ chronic/ episodic
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Frequency of patients with SCD-related Healthcare Resource Utilization (HRU)
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Frequency of patients with SCD-related Healthcare Resource Utilization (HRU) to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Number of patients with clinical laboratory parameters abnormalities
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Number of patients with clinical laboratory parameters abnormalities to be collected
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSEG101AIC05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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