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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 from 14 to 45 days after vaccination
Awards & highlights

Study Summary

This trial will study if a common cancer drug can help people with MS better respond to the COVID-19 vaccine.

Eligible Conditions
  • Multiple Sclerosis (MS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 14 to 45 days after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 14 to 45 days after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients achieving a SARS-CoV-2 immune response
Secondary outcome measures
Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants
Antibodies, Blocking
Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Ofatumumab -vaccine 4 weeks afterExperimental Treatment2 Interventions
RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)
Group II: Ofatumumab - vaccine 2 weeks priorExperimental Treatment2 Interventions
RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)
Group III: Ofatumumab - fully vaccinated, with a boosterExperimental Treatment2 Interventions
RMS 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 IV: Ofatumumab - fully vaccinatedExperimental Treatment2 Interventions
RMS participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Group V: Interferon or glatiramer acetate - fully vaccinated, with or without boosterExperimental Treatment2 Interventions
RMS 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 VI: Interferon or glatiramer acetate - vaccine 4 weeks afterActive Control2 Interventions
RMS 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
~1470
mRNA COVID-19 vaccine
2021
Completed Phase 4
~30
interferon or glatiramer acetate
2021
Completed Phase 4
~30

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,681 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
52,103 Patients Enrolled for Multiple Sclerosis

Media Library

Ofatumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04878211 — Phase 4
Multiple Sclerosis Research Study Groups: Ofatumumab - fully vaccinated, Interferon or glatiramer acetate - fully vaccinated, with or without booster, Ofatumumab - fully vaccinated, with a booster, Ofatumumab - vaccine 2 weeks prior, Ofatumumab -vaccine 4 weeks after, Interferon or glatiramer acetate - vaccine 4 weeks after
Multiple Sclerosis Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT04878211 — Phase 4
Ofatumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878211 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Ofatumumab been cleared for distribution by the FDA?

"Clinical data collected during a Phase 4 trial has determined that ofatumumab is safe, granting it an overall rating of 3."

Answered by AI

What is the total number of participants being recruited for this research?

"Affirmative, according to clinicaltrials.gov this medical trial is recruiting participants. It was first posted on June 10th 2021 and updated lastly on July 20th 2022 - with 66 patients expected from 4 different sites."

Answered by AI

Is this investigation unprecedented in its methodology?

"Since 2010, Ofatumumab has been studied in 28 active trials across 294 cities and 46 countries. The earliest trial was conducted by GlaxoSmithKline with 32 participants. Following this initial study, the drug received Phase 2 approvals."

Answered by AI

What characteristics make participants more suitable for this research?

"To be considered for this research, individuals must have a confirmed infection of covid-19 and fit the age criterion (18 - 55). At maximum, 66 participants will be accepted."

Answered by AI

Are adults eighteen and older eligible to enroll in this research study?

"To participate in the trial, prospective patients must be between 18 to 55 years old. There are 182 studies available for those younger than 18 and 1304 trials suitable for seniors over 65."

Answered by AI

What maladies have been alleviated using Ofatumumab?

"Ofatumumab is traditionally deployed to treat multiple sclerosis, however it has applications in other contexts such as refractory fludarabine and alemtuzumab treatments, those who do not qualify for fludarabine-based therapy or active secondary progressive multiple sclerosis (spms)."

Answered by AI

How many facilities are conducting this trial?

"Currently, a team of researchers is recruiting patients from 4 different study sites. These locations are situated in Sunrise, Saint Louis and Phoenix with additional sites elsewhere. It would be advantageous to select the nearest site when enrolling so that travelling requirements can be reduced."

Answered by AI

Has Ofatumumab been evaluated through any other scientific investigations?

"Ofatumumab was initially investigated in 2010 at National Institutes of Health Clinical Center, 9000 Rockville Pike. As of now, 111 clinical trials have been completed and 28 are actively seeking participants. A number of these ongoing studies take place in Sunrise, Florida."

Answered by AI

Is there capacity for additional enrollees in this research project?

"Data posted on clinicaltrials.gov displays that this experiment is seeking volunteers, having been initially listed in June of 2021 and updated as recently as July 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
2021. "A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878211.
~6 spots leftby Apr 2025
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