Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.
NCT ID: NCT05375097
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
162 participants
OBSERVATIONAL
2020-07-03
2021-05-14
Brief Summary
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Detailed Description
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Following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported:
Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits
Pre erenumab: Follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the Terveystalo database of those with consent
Post erenumab: Follow-up data after index, from the Terveystalo database of those with consent
Time frames for comparison (sick leaves and visits): One year before index vs. \>12 months erenumab after index, One year before index vs. 6-12 months of erenumab after index (patient years), sensitivity analysis
Time frames for comparison (medications): 12 months before index vs. 12 months post follow-up
Controls (triptan treated migraine patients): Corresponding time frames as in cases.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Erenumab responder patients
Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses
Erenumab
Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses
Migraine controls
Age and gender matched migraine patients on triptan medication, excluding those on botulinum toxin, erenumab and fremanezumab to benchmark the level of HCRU, sick leaves, and medication patterns
No interventions assigned to this group
Interventions
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Erenumab
Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of migraine (ICD G43)
* Consented
* Occupational healthcare
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
East Hanover, New Jersey, United States
Countries
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Related Links
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Results for CAMG334AFI03 from the Novartis Clinical Trials Results Database
Other Identifiers
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CAMG334AFI03
Identifier Type: -
Identifier Source: org_study_id
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