Relapsing Multiple SclerosisNCT04847596
A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ofatumumab and Covid-19 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 25 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 21 May 2021to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Novartis Investigative Site
Owosso, Michigan, 48867
Novartis Investigative Site
Phoenix, Arizona, 85018
Novartis Investigative Site
Plainview, New York, 11803
Novartis Investigative Site
St Louis, Missouri, 63131
About this study
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
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
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ofatumumab, Covid-19 vaccine
- Keywords
- COVID-19, vaccine, ofatumumab, SARS-coV2, antibody, open-label
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ofatumumab; Other: Covid-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days after full course vaccination (two doses)
Secondary outcomes (2)
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)
Measured: 90 days post assay 1
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.
Measured: 120 days after full course vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start21 May 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847596
- Sponsor's protocol ID
- COMB157GUS18
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37769429
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04847596
- Acronym / sponsor ID
- COMB157GUS18
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- COVID-19, vaccine, ofatumumab, SARS-coV2, antibody, open-label
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants with RMS treated with ofatumumab | – | Other: Ofatumumab, Other: Covid-19 vaccineRelapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabProspective 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. | Other | participants with RMS treated with ofatumumab |
| Covid-19 vaccineProspective 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. | Other | participants with RMS treated with ofatumumab |
Primary outcome
Proportion of participants achieving immune response - immune assay No. 1
Time frame: 14 days after full course vaccination (two doses)
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no)
2 secondary outcomes
Proportion of participants achieving immune response - immune assay No. 2
Time frame: 90 days post assay 1
Adverse events/serious adverse events
Time frame: 120 days after full course vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 37769429Bar-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.
- Results for COMB157GUS18 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving immune response - immune assay No. 1 (time frame: 14 days after full course vaccination (two doses)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.