A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

NCT06460324 | Completed

• 1 other identifier: COMB157GUS27
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status

  Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

  From 2 weeks up to 6 months post-vaccine

• Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)

  DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.

  From 2 weeks up to 6 months post-vaccine

Secondary Outcomes (22)

• Mean Age at Index Date by Vaccination Status

  Index date

• Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)

  Index date

• Gender at Index Date by Vaccination Status

  Index date

• Gender at Index Date by Prior DMT

  Index date

• Race at Index Date by Vaccination Status

  Index date

Study Arms (1)

COVID-19 Vaccination Cohort

Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination.

Eligibility Criteria

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

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
• Fully vaccinated with any FDA-authorized COVID-19 vaccination.
• Diagnosed with MS.
• Receiving ofatumumab at the time of either (or both) of the following:
• Initial COVID-19 vaccination.
• Booster vaccination.
• Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:
• Full COVID-19 vaccination course.
• Booster vaccine (among patients receiving ofatumumab at the time of the booster).

You may not qualify if:

• Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System 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: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 20, 2022
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (1)