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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT07743281

Run by

Novartis Pharmaceuticals

People needed

753

Starts

2025-03-10

Expected to finish

2025-07-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients who did not meet the inclusion criteria.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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