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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis (ALITHIOS Trial)

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

ALITHIOS 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.Check my eligibility
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.See study design
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.

ALITHIOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Secondary outcome measures
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 outcome measures
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

ALITHIOS 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
Ofatumumab
2013
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,195,645 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
50,067 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

Frequently Asked Questions

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

Has Ofatumumab been investigated in other scientific research?

"Since 2006, ofatumumab has undergone 369 clinical trials, 50 of which are still recruiting patients. There is a notable concentration of these studies in Columbus, Ohio."

Answered by AI

Are there any fatal risks associated with Ofatumumab?

"There is prior clinical evidence and data to support the safety of Ofatumumab, thus it received a score of 3."

Answered by AI

For what purpose is Ofatumumab commonly prescribed?

"Ofatumumab is an effective treatment for multiple sclerosis, active booster immunization, and refractory to fludarabine and alemtuzumab."

Answered by AI

Is the age limit for this research seventy-five years or older?

"This research is taking in individuals who have surpassed the age of 18 but have not yet reached 100 years old."

Answered by AI

Are there specific requirements for eligibility in this clinical trial?

"Eligible patients for this clinical trial must suffer from multiple sclerosis and be between 18 and 100 years old. So far, 2010 people have signed up to participate."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Georgia
Mississippi
How many prior treatments have patients received?
3+

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
2018. "Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03650114.
All > Amyotrophic Lateral Sclerosis > Paid Studies Delaware
~839 spots leftby Dec 2027
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