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

NCT05576779 | Completed

• 1 other identifier: COMB157GUS11
• Study Type: observational
• Target: 2,101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis,; ofatumumab,; disease-modifying therapy,; COVID-19

Outcome Measures

Primary Outcomes (1)

• Proportion of patients initiating ofatumumab based on DMT use

  The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.

  12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

Secondary Outcomes (34)

• Age

  Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

• Gender

  Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

• Number of patients: Geographic region

  Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

• Number of patients: State level (Geographic region)

  Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

• Number of patients: Insurance type

  Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

Study Arms (2)

Ofatumumab

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

Other: Ofatunumab

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

Interventions

Ofatunumab OTHER

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

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prescription claims for ofatumumab or other DMTs of interest.

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for COMB157GUS11 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: December 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)