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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis (KATHAROS Trial)

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 12 months
Awards & highlights

Summary

This trial will investigate if a drug called ofatumumab is present in breast milk and at what levels in women with a certain type of multiple sclerosis. The study will involve women who are breastfeeding and

Who is the study for?
This trial is for lactating women over 18 with relapsing forms of Multiple Sclerosis (RMS) who have given birth to a term infant and are exclusively breastfeeding. They must be planning to start or restart treatment with Ofatumumab between 2-24 weeks after giving birth, independent of the study.
What is being tested?
The study tests if the drug Ofatumumab, used for treating RMS, can be found in breast milk and at what levels when taken by breastfeeding mothers postpartum.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 with relapsing MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of ofatumumab in breast milk.
Secondary outcome measures
Estimation of relative infant dose of ofatumumab
Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
Plasma Pharmacokinetics of OMB157 (M/P Ratio)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OfatunumabExperimental Treatment1 Intervention
Recommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatunumab
2020
N/A
~2110

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,984 Total Patients Enrolled
104 Trials studying Multiple Sclerosis
51,790 Patients Enrolled for Multiple Sclerosis
~13 spots leftby Oct 2025
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