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Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice

NCT ID: NCT06737419

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-09

Study Completion Date

2024-02-05

Brief Summary

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This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Clinically Isolated Syndrome Relapsing-remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ofatumumab Cohort

Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
* Aged 18 years or older at index date, and
* Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
* Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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COMB157GUS15

Identifier Type: -

Identifier Source: org_study_id