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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 )

Tracking Information
First Submitted Date August 19, 2021
First Posted Date August 25, 2021
Last Update Posted Date January 13, 2023
Actual Study Start Date November 4, 2021
Estimated Primary Completion Date May 29, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India
Official Title Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India (SPOTLIGHT)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with SCD initiated on treatment with commercially available crizanlizumab at sites
Condition Sickle Cell Disease
Intervention 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.
Study Groups/Cohorts Crizanlizumab
Patients initiated on treatment with commercially available crizanlizumab
Intervention: Other: Crizanlizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 19, 2021)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 29, 2025
Estimated Primary Completion Date May 29, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Bahrain,   India,   Kuwait,   Qatar,   Saudi Arabia,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT05020873
Other Study ID Numbers CSEG101AIC05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2023