Clinical trial NCT04847596: A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Official title: An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: COVID-19
vaccine
ofatumumab
SARS-coV2
antibody
open-label
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Age 18-55 years old inclusive at Screening
3. Diagnosis of relapsing MS by 2017 revised McDonald criteria
4. Must be willing to comply with the study schedule
5. 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.
6. 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)

Exclusion Criteria:

1. Known clinical diagnosis of COVID-19 prior to screening based on investigator's or patient's personal physician's judgement
2. Has a contraindication to receiving an mRNA COVID-19 vaccine
3. Has an immediate allergic reaction to past vaccine or injection
4. 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
5. Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
6. Prior treatment with S1P agent within 2 months of study enrollment
7. Prior treatment with natalizumab within 6 months of study enrollment
8. Contraindications to ofatumumab treatment as per the USPI will be adhered to which include active infection hepatitis B infection, progressive multifocal leukoencephalopathy and pregnancy.
9. Participation in another interventional clinical trial within 14 days before enrollment.
10. Have been treated with any of the medications as described in the full protocol
11. 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

Primary outcomes:
measure: Proportion of participants achieving immune response - immune assay No. 1
timeFrame: 14 days after full course vaccination (two doses)
Secondary outcomes:
measure: Proportion of participants achieving immune response - immune assay No. 2
timeFrame: 90 days post assay 1
measure: Adverse events/serious adverse events
timeFrame: 120 days after full course vaccination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Owosso
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Plainview
country: United States
facility: Novartis Investigative Site
state: New York
city: Guaynabo
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: