MigraineNCT05375097
Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.
An observational study of Migraine, run by Novartis Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2020to 14 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients on erenumab treatment
Who may be able to join
- Adult patients on erenumab treatment ATC: N02CX07
- Diagnosis of migraine (ICD G43)
- Consented
- Occupational healthcare
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
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)
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Erenumab
- Keywords
- Erenumab,, CGRP,, real world evidence,, sick leaves,, working impairment,, health care visits,, prescriptions,, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Erenumab | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: throughout the study, approximately 2 years
Secondary outcomes (4)
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.
Measured: throughout the study, approximately 2 years
Change in number of healthcare visits (head-ache related)
Number of headache related healthcare visits were reported.
Measured: throughout the study, approximately 2 years
Change in number of healthcare visits (all cause)
Number of healthcare visits were reported.
Measured: throughout the study, approximately 2 years
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.
Measured: throughout the study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start3 Jul 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375097
- Sponsor's protocol ID
- CAMG334AFI03
- Status last verified
- Jun 2022
- First submitted
- 10 May 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05375097
- Acronym / sponsor ID
- CAMG334AFI03
- Conditions
- Migraine
- Keywords
- Erenumab,, CGRP,, real world evidence,, sick leaves,, working impairment,, health care visits,, prescriptions,, migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erenumab responder patients | – | Other: ErenumabPatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients on erenumab treatment
Key inclusion criteria (4 listed)
- Adult patients on erenumab treatment ATC: N02CX07
- Diagnosis of migraine (ICD G43)
- Consented
- Occupational healthcare
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabPatients 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 | Other | Erenumab responder patients |
Primary outcome
Number of sick leave days (headache)
Time frame: throughout the study, approximately 2 years
Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.
4 secondary outcomes
Change in number of sick leave days (all cause)
Time frame: throughout the study, approximately 2 years
Change in number of healthcare visits (head-ache related)
Time frame: throughout the study, approximately 2 years
Change in number of healthcare visits (all cause)
Time frame: throughout the study, approximately 2 years
Medication patterns: Number of patients receiving medications of interest
Time frame: throughout the study, approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Results for CAMG334AFI03 from the Novartis Clinical Trials Results DatabaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sick leave days (headache) (time frame: throughout the study, approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.