Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.

NCT ID: NCT05576779

Last Updated: 2022-11-08

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

2101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-03

Study Completion Date

2021-12-31

Brief Summary

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This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.

Detailed Description

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The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.

Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.

The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ofatumumab

all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Ofatunumab

Intervention Type OTHER

All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Non-ofatumumab

patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate

No interventions assigned to this group

Interventions

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Ofatunumab

All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.

-. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
* Patients with linkage to the Dx database.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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 Investigative Site

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17981

Results for COMB157GUS11 from the Novartis Clinical Trials Website

Other Identifiers

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COMB157GUS11

Identifier Type: -

Identifier Source: org_study_id

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