Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07821411

A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan

This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, CH-4056, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:

  • Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
  • Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
  • Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
  • Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).

Exclusion criteria

Patients will be excluded if they meet any of the following criteria:

  • Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
  • Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Proportion of Patients Persistent With OMB

    Time frame: 6 months, 12 months

    Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).

  2. Proportion of Patients Adherent to OMB

    Time frame: 6 months, 12 months

    Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.

Secondary outcomes

  1. Number of Treatments Used

    Time frame: Baseline, up to approximately 4 years

  2. Number of Patients by Sequence of Treatments Used

    Time frame: Baseline, up to approximately 4 years

  3. Number of Patients by Line of Therapy (LOT)

    Time frame: Baseline, up to approximately 4 years

  4. Number of Patients by Type of Treatment

    Time frame: Baseline, up to approximately 4 years

  5. Duration of Treatment

    Time frame: Baseline, up to approximately 4 years

  6. Percentage of Patients Who Switch Treatment

    Time frame: Up to approximately 4 years

    Percentage of patients who switch from OMB treatment to another DMT.

  7. Percentage of Patients Who Discontinue OMB Treatment

    Time frame: Up to approximately 4 years

  8. Number of Patients by Treatments Received After OMB Treatment

    Time frame: Up to approximately 4 years

  9. Baseline Demographics

    Time frame: Baseline

  10. Number of Patients by Index Year

    Time frame: Baseline

    Index year is the year of index date. Index date is the date of first claim for OMB or DMT.

  11. Charlson Comorbidity Index (CCI) Score

    Time frame: Baseline

    CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2).

  12. Number of Patients per Top 10 Comorbidities Observed During the Baseline Period

    Time frame: Baseline

  13. Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period

    Time frame: Baseline

  14. Number of Hospitalizations Per Person Year

    Time frame: Baseline

    RMS-specific and all-cause hospitalizations.

  15. Number of Relapses Per Person Year

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real-World Outcomes of Ofatumumab: Relapse Rates, Disease Progression, and Treatment Patterns in Germany and Japan

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.