Multiple SclerosisNCT06459232
Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies
An observational study of Multiple Sclerosis, run by Novartis at 1 site in United States.
Trial summary
This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 17 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.
- With 1 or more MS diagnosis for 12 months prior to the index date [inclusive].
- Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date [inclusive].
- Include patients who were 18 years or older on the index date.
- Include patients continuously enrolled in pharmacy and medical benefits from the index date [inclusive] to 6 months/12 months post-index date.
Who cannot join
- Patients with 1 or more claims of index drug within 12 months prior to index date.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies
This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.
The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) Cohort | Adult MS patients with at least 1 claim of siponimod or an MS-related FDA-approved DMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Number of Patients with a Minimum of 12 Months Follow-up by DMT Use
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Secondary outcomes (21)
Mean Age
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Age Group
Age group categories included:
- 18-34 years
- 35-44 years
- 45-54 years
- 55-64 years
- 65+ years
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Age Group
Age group categories included:
- 18-34 years
- 35-44 years
- 45-54 years
- 55-64 years
- 65+ years
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 months Follow-up by Gender
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 months Follow-up by Gender
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type
Measured: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Percentage of Patients with MS Relapses
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Mean Charlson Comorbidity Index (CCI) Score
CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level
Disability levels included: No symptoms, Mild, Moderate, and Severe.
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level
Disability levels included: No symptoms, Mild, Moderate, and Severe.
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT
Measured: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up
Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.
Measured: 6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up
Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.
Measured: 12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start19 Nov 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
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.
- 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459232
- Sponsor's protocol ID
- CBAF312AUS16
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies
- ClinicalTrials.gov ID
- NCT06459232
- Acronym / sponsor ID
- CBAF312AUS16
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 14 Jun 2024 (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 retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.
The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) Cohort | – | –Adult MS patients with at least 1 claim of siponimod or an MS-related FDA-approved DMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (5 listed)
- With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.
- With 1 or more MS diagnosis for 12 months prior to the index date [inclusive].
- Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date [inclusive].
- Include patients who were 18 years or older on the index date.
- Include patients continuously enrolled in pharmacy and medical benefits from the index date [inclusive] to 6 months/12 months post-index date.
Key exclusion criteria (1 listed)
- Patients with 1 or more claims of index drug within 12 months prior to index date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Number of Patients with a Minimum of 12 Months Follow-up by DMT Use
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
21 secondary outcomes
Mean Age
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Age Group
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Age Group
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 months Follow-up by Gender
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 months Follow-up by Gender
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type
Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Percentage of Patients with MS Relapses
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Mean Charlson Comorbidity Index (CCI) Score
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT
Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up
Time frame: 6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up
Time frame: 12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
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 14 Jun 2024.
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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 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 5 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 14 Jun 2024. 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 Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use (time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)). The study lists 2 primary outcomes in all. 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 14 Jun 2024.