Clinical trial NCT05375097: Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Erenumab,
CGRP,
real world evidence,
sick leaves,
working impairment,
health care visits,
prescriptions,
migraine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients on erenumab treatment

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients on erenumab treatment ATC: N02CX07
* Diagnosis of migraine (ICD G43)
* Consented
* Occupational healthcare

Exclusion Criteria:

None

Primary outcomes:
measure: Number of sick leave days (headache)
timeFrame: throughout the study, approximately 2 years
Secondary outcomes:
measure: Change in number of sick leave days (all cause)
timeFrame: throughout the study, approximately 2 years
measure: Change in number of healthcare visits (head-ache related)
timeFrame: throughout the study, approximately 2 years
measure: Change in number of healthcare visits (all cause)
timeFrame: throughout the study, approximately 2 years
measure: Medication patterns: Number of patients receiving medications of interest
timeFrame: throughout the study, approximately 2 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: