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

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ClinicalTrials.gov Identifier: NCT05020873
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Sickle Cell Disease Other: Crizanlizumab

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 Design
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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India (SPOTLIGHT)
Actual Study Start Date : November 4, 2021
Estimated Primary Completion Date : May 29, 2025
Estimated Study Completion Date : May 29, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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


  9. 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


  10. 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

  11. 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

  12. 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

  13. 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

  14. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with SCD initiated on treatment with commercially available crizanlizumab at sites
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020873


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Bahrain
Novartis Investigative Site Recruiting
Manama, Bahrain, 20525
India
Novartis Investigative Site Recruiting
Vishakhapatnam, Andhra Pradesh, India, 530002
Novartis Investigative Site Recruiting
Guwahati, India, 781003
Kuwait
Novartis Investigative Site Recruiting
Al Ahmadi, Kuwait, 52700
Qatar
Novartis Investigative Site Recruiting
Doha, Qatar, 305
Saudi Arabia
Novartis Investigative Site Recruiting
Dammam, Saudi Arabia, 32263
Novartis Investigative Site Recruiting
Jazan, Saudi Arabia, 82943
United Arab Emirates
Novartis Investigative Site Recruiting
Al Ain Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05020873    
Other Study ID Numbers: CSEG101AIC05
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
NIS
sickle cell disease
SCD
crizanlizumab
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn