Multiple SclerosisNCT05141669
Impact of Fingolimod Adherence on Outcomes
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fingolimod
- How many people
- 694 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 20 Nov 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study comprised of commercial and Medicare Advantage with Part D (MAPD) enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018.
Who may be able to join
- ≥18 years old during year of index date with valid gender and geographic information
- Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
- CE with medical and pharmacy benefits for ≥18 months (540 days) beginning on the index date (post-index period)
- All patients had uniform 6-month pre-index and 18-month post-index periods
- ≥1 medical claim with an MS diagnosis codei in any position during the pre-or post-index periods
- ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)
- By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used.
Who cannot join
- •≥1 pharmacy or medical claim for any MS DMT during the pre-index period
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigational Site
East Hanover, New Jersey, 07936-1080
About this study
This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.
Read the detailed description
The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018. The date of the first fingolimod pharmacy claim during the identification period was the index date.
All patients were continuously enrolled in the health plan for 24 months. The 6-month pre-index period, ending the day before the index date, was used to assess patients' clinical characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period started on the index date. The first 6 months of the post-index period (initiation period) were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period (post-initiation period) were used to measure adherence and outcomes. The 24-month observation period for each patient comprised the 6-month pre-index and 18-month post-index periods.
- Conditions
- Multiple Sclerosis
- Being tested
- Fingolimod
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Participants who initiated fingolimod to treat multiple sclerosis (MS)
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | Participants who initiated fingolimod to treat multiple sclerosis (MS) Receives: Drug: Fingolimod | |
| Non-fingolimod Disease Modifying Treatment (DMT) | All patients with ≥ 1 medical or pharmacy claim for a DMT other than fingolimod. Among patients included in the study that those with ≥ 1 pharmacy or medical claim for any MS DMT during pre-index would be excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Multiple Sclerosis (MS) relapses
Number of Multiple Sclerosis (MS) relapses were reported to estimate the effect of fingolimod adherence on the odds of MS relapse in a 12-month period
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Secondary outcomes (5)
Number of Multiple Sclerosis-related inpatient admission
Number of any Multiple Sclerosis-related inpatient admission were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Number of Multiple Sclerosis-related Emergency Room (ER) visits
Number of Multiple Sclerosis-related ER visits were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs
All-cause total (i.e., pharmacy + medical costs) were computed as the combined health plan and patient paid amounts for all claims, regardless of diagnoses recorded. Medical costs comprised sub-categories of ambulatory costs (physician office and hospital outpatient), emergency services costs, inpatient costs, and other medical costs.
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause medical health care costs
Medical health care costs were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs excluding fingolimod
Total (medical plus pharmacy) health care costs excluding fingolimod were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.
Measured: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start18 May 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 694 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
- NCT05141669
- Sponsor's protocol ID
- CFTY720DUS45
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fingolimod Adherence on Outcomes
- ClinicalTrials.gov ID
- NCT05141669
- Acronym / sponsor ID
- CFTY720DUS45
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 2 Dec 2021 (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 study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.
Detailed description
The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018. The date of the first fingolimod pharmacy claim during the identification period was the index date.
All patients were continuously enrolled in the health plan for 24 months. The 6-month pre-index period, ending the day before the index date, was used to assess patients' clinical characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period started on the index date. The first 6 months of the post-index period (initiation period) were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period (post-initiation period) were used to measure adherence and outcomes. The 24-month observation period for each patient comprised the 6-month pre-index and 18-month post-index periods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | – | Drug: FingolimodParticipants who initiated fingolimod to treat multiple sclerosis (MS) |
| Non-fingolimod Disease Modifying Treatment (DMT) | – | –All patients with ≥ 1 medical or pharmacy claim for a DMT other than fingolimod. Among patients included in the study that those with ≥ 1 pharmacy or medical claim for any MS DMT during pre-index would be excluded. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study comprised of commercial and Medicare Advantage with Part D (MAPD) enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018.
Key inclusion criteria (7 listed)
- ≥18 years old during year of index date with valid gender and geographic information
- Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
- CE with medical and pharmacy benefits for ≥18 months (540 days) beginning on the index date (post-index period)
- ≥1 medical claim with an MS diagnosis codei in any position during the pre-or post-index periods
- ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)
Key exclusion criteria (1 listed)
- •≥1 pharmacy or medical claim for any MS DMT during the pre-index period
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 |
|---|---|---|
| FingolimodParticipants who initiated fingolimod to treat multiple sclerosis (MS) | Drug | Fingolimod |
Primary outcome
Number of Multiple Sclerosis (MS) relapses
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Number of Multiple Sclerosis (MS) relapses were reported to estimate the effect of fingolimod adherence on the odds of MS relapse in a 12-month period
5 secondary outcomes
Number of Multiple Sclerosis-related inpatient admission
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Number of Multiple Sclerosis-related Emergency Room (ER) visits
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause medical health care costs
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs excluding fingolimod
Time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
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 16 Dec 2021.
- Results for CFTY720DUS45 from the Novartis Clinical Trials WebsiteLink 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 Multiple Sclerosis, 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 7 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 16 Dec 2021. 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 Multiple Sclerosis (MS) relapses (time frame: Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)). 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 16 Dec 2021.