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A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse

Treatment Patterns and Annualized Relapse Rate in Patients With Multiple Sclerosis Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07743281
Enrollment
753
Registered
2026-08-03
Start date
2025-03-10
Completion date
2025-07-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Disease modifying therapy, Relapse, Escalation

Brief 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. 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.

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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. * ≥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.

Exclusion criteria

• Patients who did not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Proportion of Patients Who Remain on the Same Platform DMT, Switch to Another Platform DMT, or Escalate to a High-efficacy DMTUp to approximately 7 years, 4 months

Secondary

MeasureTime frameDescription
Time From First Relapse on a Platform Oral or Injectable DMT to Switch to Another Platform DMT and Escalation to a High-efficacy DMTUp to approximately 7 years, 4 months
Annualized Relapse Rate (ARR)Up to approximately 7 years, 4 monthsARR was defined as the number of relapse episodes per patient-year (PPY).

Countries

United States

Contacts

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026