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A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Primary Purpose

Relapsing Multiple Sclerosis (RMS)

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab
mRNA COVID-19 vaccine
interferon or glatiramer acetate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis (RMS) focused on measuring Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study
  • Diagnosis of relapsing MS by 2017 revised McDonald criteria
  • Willing to comply with the study schedule
  • Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
  • Eligible to receive and plan to be started on ofatumumab OR currently on prescribed ofatumumab for ≥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for ≥ 4 weeks

Exclusion Criteria:

  • Already has received Pfizer, Moderna or Johnson & Johnson vaccine
  • Known diagnosis of COVID-19 prior to screening
  • Has a contraindication to receiving an mRNA COVID-19 vaccine
  • Has an immediate allergic reaction to past vaccine or injection
  • Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ofatumumab - vaccine 2 weeks prior

Ofatumumab -vaccine 4 weeks after

Interferon or glatiramer acetate - vaccine 4 weeks after

Arm Description

RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)

RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)

RMS participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate

Outcomes

Primary Outcome Measures

Percentage of patients achieving a SARS-CoV-2 immune response
An immune response is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody assay 14 days after 2nd vaccination dose is received

Secondary Outcome Measures

Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants
A sustained immune response to non-mRNA COVID vaccine is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody after more than 14 days up to approximately one year after 2nd vaccination dose is received.
Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants
Immune conversion to non-live mRNA COVID-19 vaccine is defined as either: Baseline absence of SARS-CoV-2 spike IgG with post-vaccination SARS-CoV-2 positive qualitative antibody assay 14 days after 2nd vaccination dose is received OR Baseline serum presence of SARS-CoV-2 quantitative IgG antibody with post-vaccination ≥ 4-fold increase in SARS-CoV-2 quantitative antibody titer as determined by dilution assay 14 days after 2nd vaccination dose is received
Percentage of patients developing a neutralizing antibody
Neutralizing antibody development is defined as positive SARS-CoV-2 neutralization antibody assay 14 days after 2nd vaccination dose is received.

Full Information

First Posted
May 3, 2021
Last Updated
September 15, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04878211
Brief Title
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Official Title
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Novartis business decision, not related to safety.
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
Detailed Description
This is a three-cohort, multicenter, prospective study of up to 66 relapsing MS participants. The first cohort will be participants receiving an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. The second cohort will be participants receiving an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. The third cohort will be participants currently on an interferon or glatiramer acetate planning to receive COVID-19 mRNA vaccine. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis (RMS)
Keywords
Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ofatumumab - vaccine 2 weeks prior
Arm Type
Experimental
Arm Description
RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)
Arm Title
Ofatumumab -vaccine 4 weeks after
Arm Type
Experimental
Arm Description
RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)
Arm Title
Interferon or glatiramer acetate - vaccine 4 weeks after
Arm Type
Active Comparator
Arm Description
RMS participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Intervention Description
3 loading doses followed by monthly administrations
Intervention Type
Biological
Intervention Name(s)
mRNA COVID-19 vaccine
Intervention Description
Pfizer or Moderna mRNA Vaccine
Intervention Type
Drug
Intervention Name(s)
interferon or glatiramer acetate
Intervention Description
iDMT
Primary Outcome Measure Information:
Title
Percentage of patients achieving a SARS-CoV-2 immune response
Description
An immune response is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody assay 14 days after 2nd vaccination dose is received
Time Frame
Vaccination up to 14 days
Secondary Outcome Measure Information:
Title
Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants
Description
A sustained immune response to non-mRNA COVID vaccine is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody after more than 14 days up to approximately one year after 2nd vaccination dose is received.
Time Frame
From 14 to 45 days after vaccination
Title
Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants
Description
Immune conversion to non-live mRNA COVID-19 vaccine is defined as either: Baseline absence of SARS-CoV-2 spike IgG with post-vaccination SARS-CoV-2 positive qualitative antibody assay 14 days after 2nd vaccination dose is received OR Baseline serum presence of SARS-CoV-2 quantitative IgG antibody with post-vaccination ≥ 4-fold increase in SARS-CoV-2 quantitative antibody titer as determined by dilution assay 14 days after 2nd vaccination dose is received
Time Frame
Vaccination up to 14 days
Title
Percentage of patients developing a neutralizing antibody
Description
Neutralizing antibody development is defined as positive SARS-CoV-2 neutralization antibody assay 14 days after 2nd vaccination dose is received.
Time Frame
Vaccination up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study Diagnosis of relapsing MS by 2017 revised McDonald criteria Willing to comply with the study schedule Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab Eligible to receive and plan to be started on ofatumumab OR currently on prescribed ofatumumab for ≥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for ≥ 4 weeks Exclusion Criteria: Already has received Pfizer, Moderna or Johnson & Johnson vaccine Known diagnosis of COVID-19 prior to screening Has a contraindication to receiving an mRNA COVID-19 vaccine Has an immediate allergic reaction to past vaccine or injection Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
Facility Information:
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Novartis Investigative Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Novartis Investigative Site
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Novartis Investigative Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novartis Investigative Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Learn more about this trial

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

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