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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis (ALITHIOS Trial)

Phase 3
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 older than 18 years old
Must not have
Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the first 5 years of the study.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will look at the long-term effects of a Novartis MS drug, specifically on how it affects the body's response to vaccinations and a protein called KLH.

Who is the study for?
This trial is for people with relapsing multiple sclerosis who were in a previous Novartis ofatumumab study and received continuous treatment. They must have had certain vaccinations before, not be pregnant or nursing, and can't join if they've had serious infections, allergies to vaccines or egg/shellfish, or recent safety issues with the drug.
What is being tested?
The study is looking at the long-term effects of Ofatumumab on MS patients' health. It also includes a sub-study testing how well these patients respond to vaccines like flu shots and pneumococcal vaccines while taking Ofatumumab.
What are the potential side effects?
Possible side effects include reactions related to immune system suppression such as increased risk of infections. There may also be allergic reactions due to vaccine components or Ofatumumab itself.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any active infections or chronic conditions like AIDS.
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I am not on any medications that the study does not allow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the first 5 years of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the first 5 years of the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
Changes in neurofilament light change serum concentration
Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
+6 more
Other study objectives
Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab
Polyvalent pneumococcal vaccine
Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)
+3 more

Awards & Highlights

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment6 Interventions
Subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seasonal Quadrivalent influenza vaccine
2018
Completed Phase 3
~1890
13-valent pneumococcal conjugate vaccine (13-PCV)
2018
Completed Phase 3
~1890
Keyhole limpet hemocyanin (KLH) neo-antigen
2018
Completed Phase 3
~1890
Tetanus toxoid (TT) containing vaccine (Td, Tdap)
2018
Completed Phase 3
~1890
Ofatumumab
2013
Completed Phase 3
~1460
23-valent pneumococcal polysaccharide vaccine (23-PPV)
2018
Completed Phase 3
~1890

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,251,971 Total Patients Enrolled
107 Trials studying Multiple Sclerosis
49,906 Patients Enrolled for Multiple Sclerosis

Media Library

Multiple Sclerosis Research Study Groups: Ofatumumab
Multiple Sclerosis Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT03650114 — Phase 3
~627 spots leftby Dec 2027
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