NCT04847596

Brief Summary

This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

April 14, 2021

Last Update Submit

January 23, 2023

Conditions

Relapsing Multiple Sclerosis

Keywords

COVID-19vaccineofatumumabSARS-coV2antibodyopen-label

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants achieving immune response - immune assay No. 1

    Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no)

    14 days after full course vaccination (two doses)

Secondary Outcomes (2)

  • Proportion of participants achieving immune response - immune assay No. 2

    90 days post assay 1

  • Adverse events/serious adverse events

    120 days after full course vaccination

Study Arms (1)

participants with RMS treated with ofatumumab

Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment

Other: OfatumumabOther: Covid-19 vaccine

Interventions

OfatumumabOTHER

Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

participants with RMS treated with ofatumumab
Covid-19 vaccineOTHER

Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.

participants with RMS treated with ofatumumab

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment

You may qualify if:

  • Signed informed consent must be obtained prior to participation in the study
  • Age 18-55 years old inclusive at Screening
  • Diagnosis of relapsing MS by 2017 revised McDonald criteria
  • Must be willing to comply with the study schedule
  • Have received/scheduled vaccination with a FDA approved for emergency use COVID-19 mRNA vaccine (either Pfizer or Moderna) (i) either been scheduled for vaccine, (ii) received a single vaccine with a scheduled second dose, or (iii) already completed full course (two dose) vaccination.
  • Currently receiving ofatumumab for the treatment of RMS (Preoftumumab serology with Hepatitis B testing showing no active or latent infection, as well as serum IgG results to be recorded in the database if available)

You may not qualify if:

  • Known clinical diagnosis of COVID-19 prior to screening based on investigator's or patient's personal physician's judgement
  • Has a contraindication to receiving an mRNA COVID-19 vaccine
  • Has an immediate allergic reaction to past vaccine or injection
  • Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to vaccination as determined by the HCP
  • Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
  • Prior treatment with S1P agent within 2 months of study enrollment
  • Prior treatment with natalizumab within 6 months of study enrollment
  • Contraindications to ofatumumab treatment as per the USPI will be adhered to which include active infection hepatitis B infection, progressive multifocal leukoencephalopathy and pregnancy.
  • Participation in another interventional clinical trial within 14 days before enrollment.
  • Have been treated with any of the medications as described in the full protocol
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Phoenix, Arizona, 85018, United States

Location

Novartis Investigative Site

Owosso, Michigan, 48867, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63131, United States

Location

Novartis Investigative Site

Plainview, New York, 11803, United States

Location

Novartis Investigative Site

Guaynabo, 00968, Puerto Rico

Location

Related Publications (1)

  • Bar-Or A, Aburashed R, Chinea AR, Hendin BA, Lucassen E, Meng X, Stankiewicz J, Tullman MJ, Cross AH. Humoral immune response to COVID-19 mRNA vaccines in patients with relapsing multiple sclerosis treated with ofatumumab. Mult Scler Relat Disord. 2023 Nov;79:104967. doi: 10.1016/j.msard.2023.104967. Epub 2023 Aug 28.

    PMID: 37769429DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

ofatumumabCOVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 19, 2021

Study Start

May 21, 2021

Primary Completion

February 18, 2022

Study Completion

February 18, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)PR(1)