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OpenTrials
Completed

NCT Number: NCT07743281

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Annualized Relapse Rate (ARR)

    Time frame: Up to approximately 7 years, 4 months

    ARR was defined as the number of relapse episodes per patient-year (PPY).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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