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Monoclonal Antibodies
Ofatumumab for Multiple Sclerosis
Phase 4
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up vaccination up to 70, 180, 270 and 360 days
Awards & highlights
Summary
This trial tests if MS patients on ofatumumab can develop an immune response to the COVID-19 vaccine. Ofatumumab is given as a regular injection and works by reducing specific immune cells. The study includes different groups based on when they receive the vaccine relative to starting ofatumumab.
Eligible Conditions
- Multiple Sclerosis (MS)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ vaccination up to 70, 180, 270 and 360 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vaccination up to 70, 180, 270 and 360 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Secondary study objectives
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + boosterExperimental Treatment2 Interventions
Participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Group II: Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± boosterExperimental Treatment2 Interventions
Participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks.
Group III: Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKsExperimental Treatment2 Interventions
Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Group IV: Cohort 2 - vaccine 4 WKs after OMB157Experimental Treatment2 Interventions
Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).
Group V: Cohort 1 - 2 WKs vaccine prior to OMB157Experimental Treatment2 Interventions
Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).
Group VI: Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs afterActive Control2 Interventions
Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,980 Total Patients Enrolled
104 Trials studying Multiple Sclerosis
51,786 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must wait at least two weeks after getting the Pfizer or Moderna COVID-19 vaccine before starting treatment with ofatumumab.You have had a serious infection that required you to stay in the hospital or receive strong antibiotics through a vein within the past two weeks.You cannot get the mRNA COVID-19 vaccine because of a medical reason.You have had an allergic reaction to a vaccine or injection in the past.You are currently taking ofatumumab for at least 4 weeks or plan to start taking it. Alternatively, you are currently taking interferon or glatiramer acetate for at least 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - 2 WKs vaccine prior to OMB157
- Group 2: Cohort 2 - vaccine 4 WKs after OMB157
- Group 3: Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after
- Group 4: Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs
- Group 5: Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster
- Group 6: Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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