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NCT07743281

Overview

NCT ID: NCT07743281
Lead Sponsor: Novartis PharmaceuticalsINDUSTRY
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
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.
Conditions: Multiple Sclerosis
Interventions

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Mar 10, 2025Actual
Primary Completion Date: Jul 30, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 753Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Novartis

Similar Studies

Participant Group/Arms

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).