Multiple SclerosisNCT07743281
A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs, as well as time to switching DMTs after relapse. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 753 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 30 Jul 2025
- 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 MS patients who relapsed on a platform oral or injectable DMT in real-world practice during the patient identification period, between March 28, 2017 and July 31, 2023.
Who may be able to join
- Patients in the Base Sample were required to meet the following eligibility criteria:
- Incident claim for a platform oral or injectable DMT in the patient identification period (Mar 28, 2017 - Jul 31, 2023).
- Treatment initiation date is the first qualifying DMT claim date.
- Initial treatment is the DMT recorded on treatment initiation date.
- No claim for a different DMT used for the treatment of multiple sclerosis (MS) on the treatment initiation date.
- ≥18 years of age on treatment initiation date.
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- ≥2 outpatient medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to the treatment initiation date and the second claim up to 6 months after treatment initiation date, or ≥1 inpatient claim with a diagnosis of MS in the first position in the 12 months prior to or on treatment initiation date.
- ≥1 relapse recorded after ≥3 months of persistent use of initial treatment and during period of persistence on initial treatment.
- o Index relapse date is the start date of earliest qualifying relapse episode in the initial treatment period.
- Continuous healthcare plan enrollment for ≥12 months prior to treatment initiation date and ≥12 months after index relapse date.
- Patients in Cohort 1 and Cohort 2 included patients meeting the following criteria:
- Included in Base Sample.
- ≥1 claim for a platform oral, platform injectable, or high-efficacy DMT during the switch eligibility period (12-month period after index relapse date).
- o For the high-efficacy DMT patients, index treatment date is the date of the first claim for a high-efficacy DMT during the switch eligibility period. For patients who remain on the initial treatment or switch to another DMT, the index treatment date is the date of the claim for the initial treatment that falls in the exposure set and meets matching criteria.
- Continuous healthcare plan enrollment and persistent use of index DMT for ≥6 months after index treatment date.
Who cannot join
- Patients who did not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Annualized Relapse Rate in Patients With Multiple Sclerosis Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse: A Retrospective Cohort Study
The aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs, as well as time to switching DMTs after relapse. Clinical effectiveness was characterized by comparing treatment failure rates in patients who escalate to high-efficacy DMTs versus those who remain on platform DMTs following initial relapse.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Disease modifying therapy, Relapse, Escalation
- Medical subject headings
- Multiple Sclerosis, Recurrence
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 |
|---|---|---|
| Base Sample | Adult patients with MS who relapsed on a platform oral or injectable DMT in real-world practice between March 28, 2017 and July 31, 2023. | |
| Cohort 1: Patients Who Remain on Platform DMT | A subcohort of the Base Sample. Patients with platform oral or injectable DMT as initial treatment who remained on initial oral DMT (InODMT), switched from platform oral to another platform oral DMT (POPO), switched from platform oral to platform injectable DMT (POPI), remained on initial injectable DMT (InIDMT), switched from platform injectable to another platform injectable DMT (PIPI), or switched from platform injectable to platform oral DMT (PIPO). | |
| Cohort 2: Patients Who Switch to High-efficacy DMT | A subcohort of the Base Sample. Patients who escalated from platform oral to high-efficacy DMT (POHE) or escalated from platform injectable to high-efficacy DMT (PIHE). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Remain on the Same Platform DMT, Switch to Another Platform DMT, or Escalate to a High-efficacy DMT
Measured: Up to approximately 7 years, 4 months
Secondary outcomes (2)
Time From First Relapse on a Platform Oral or Injectable DMT to Switch to Another Platform DMT and Escalation to a High-efficacy DMT
Measured: Up to approximately 7 years, 4 months
Annualized Relapse Rate (ARR)
ARR was defined as the number of relapse episodes per patient-year (PPY).
Measured: Up to approximately 7 years, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start10 Mar 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
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
- 753 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
- NCT07743281
- Sponsor's protocol ID
- CBAF312AUS18
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Annualized Relapse Rate in Patients With Multiple Sclerosis Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07743281
- Acronym / sponsor ID
- CBAF312AUS18
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Disease modifying therapy, Relapse, Escalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 Aug 2026 (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.
The aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs, as well as time to switching DMTs after relapse. Clinical effectiveness was characterized by comparing treatment failure rates in patients who escalate to high-efficacy DMTs versus those who remain on platform DMTs following initial relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Base Sample | – | –Adult patients with MS who relapsed on a platform oral or injectable DMT in real-world practice between March 28, 2017 and July 31, 2023. |
| Cohort 1: Patients Who Remain on Platform DMT | – | –A subcohort of the Base Sample. Patients with platform oral or injectable DMT as initial treatment who remained on initial oral DMT (InODMT), switched from platform oral to another platform oral DMT (POPO), switched from platform oral to platform injectable DMT (POPI), remained on initial injectable DMT (InIDMT), switched from platform injectable to another platform injectable DMT (PIPI), or switched from platform injectable to platform oral DMT (PIPO). |
| Cohort 2: Patients Who Switch to High-efficacy DMT | – | –A subcohort of the Base Sample. Patients who escalated from platform oral to high-efficacy DMT (POHE) or escalated from platform injectable to high-efficacy DMT (PIHE). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult MS patients who relapsed on a platform oral or injectable DMT in real-world practice during the patient identification period, between March 28, 2017 and July 31, 2023.
Key inclusion criteria (15 listed)
- Incident claim for a platform oral or injectable DMT in the patient identification period (Mar 28, 2017 - Jul 31, 2023).
- No claim for a different DMT used for the treatment of multiple sclerosis (MS) on the treatment initiation date.
- ≥18 years of age on treatment initiation date.
- ≥2 outpatient medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to the treatment initiation date and the second claim up to 6 months after treatment initiation date, or ≥1 inpatient claim with a diagnosis of MS in the first position in the 12 months prior to or on treatment initiation date.
- ≥1 relapse recorded after ≥3 months of persistent use of initial treatment and during period of persistence on initial treatment.
Key exclusion criteria (1 listed)
- Patients who did not meet the inclusion criteria.
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
Proportion of Patients Who Remain on the Same Platform DMT, Switch to Another Platform DMT, or Escalate to a High-efficacy DMT
Time frame: Up to approximately 7 years, 4 months
2 secondary outcomes
Time From First Relapse on a Platform Oral or Injectable DMT to Switch to Another Platform DMT and Escalation to a High-efficacy DMT
Time frame: Up to approximately 7 years, 4 months
Annualized Relapse Rate (ARR)
Time frame: Up to approximately 7 years, 4 months
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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 15 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 3 Aug 2026. 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?
Proportion of Patients Who Remain on the Same Platform DMT, Switch to Another Platform DMT, or Escalate to a High-efficacy DMT (time frame: Up to approximately 7 years, 4 months). 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 3 Aug 2026.