Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.

Migraine Clinical Trial

Official title:

Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities Based on Occupational Health Care Registry in Finland: an Observational Retrospective Mirror-image Study (REFI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375097
• Other study ID #: CAMG334AFI03
• Status: Completed
• Start date: July 3, 2020
• Est. completion date: May 14, 2021

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.

Description:

Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients on erenumab treatment ATC: N02CX07

• Diagnosis of migraine (ICD G43)

• Consented

• Occupational healthcare

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sick leave days (headache)	Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.	throughout the study, approximately 2 years
Secondary	Change in number of sick leave days (all cause)	Sick leaves included all registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.	throughout the study, approximately 2 years
Secondary	Change in number of healthcare visits (head-ache related)	Number of headache related healthcare visits were reported.	throughout the study, approximately 2 years
Secondary	Change in number of healthcare visits (all cause)	Number of healthcare visits were reported.	throughout the study, approximately 2 years
Secondary	Medication patterns: Number of patients receiving medications of interest	The number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported.	throughout the study, approximately 2 years

External Links

•   Results for CAMG334AFI03 from the Novartis Clinical Trials Results Database