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

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847596
• Other study ID #: COMB157GUS18
• Status: Completed
• Start date: May 21, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: January 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Ofatumumab
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.
• Covid-19 vaccine
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.

Locations

Country	Name	City	State
Puerto Rico	Novartis Investigative Site	Guaynabo
United States	Novartis Investigative Site	Owosso	Michigan
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Plainview	New York
United States	Novartis Investigative Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants achieving immune response - immune assay No. 2	Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay 90 days after assay No. 1 (yes/no)	90 days post assay 1
Secondary	Adverse events/serious adverse events	An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.; Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.	120 days after full course vaccination

External Links

•   Results for COMB157GUS18 from the Novartis Clinical Trials Website