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Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

(KATHAROS)

Sponsored by Novartis Pharmaceuticals

Quick Self-Assessment

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 23, 2026

Phase

Clinical Trial

Sponsor

Novartis Pharmaceuticals

Enrollment Target

20

Start Date

Nov 2024

πŸ“Š
1 of 20 participants interested
5% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

Who Can Participate

Inclusion Criteria

Written informed consent must be obtained before any study assessment is performed. 2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent. 3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples. 4. Participant has delivered term infant (at least 37 weeks gestation). 5. Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.

Exclusion Criteria

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. 2. Participant taking

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

πŸ“‹

Study Type

INTERVENTIONAL

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Target Enrollment

20 participants

πŸŽ‚

Age Range

18 Years - 100 Years

⚧

Gender

FEMALE

🏒

Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

ACTIVE_NOT_RECRUITING

San Francisco

California

Location available
View San Francisco location page
COMPLETED

Aurora

Colorado

Location available
View Aurora location page
ACTIVE_NOT_RECRUITING

Winfield

Illinois

Location available
View Winfield location page
ACTIVE_NOT_RECRUITING

Brookline

Massachusetts

Location available
View Brookline location page
RECRUITING

Durham

North Carolina

Location available
View Durham location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Express your interest in this groundbreaking clinical trial

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Find More Multiple Sclerosis Trials by City

Browse all multiple sclerosis clinical trials in these cities β€” not just this study.

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Looking for Multiple Sclerosis Treatment in San Francisco?

Join others in California exploring innovative treatment options through clinical research

Multiple Sclerosis Treatment Options in San Francisco, California

If you're searching for Multiple Sclerosis treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco, Aurora, Winfield and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Multiple Sclerosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Multiple Sclerosis?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Multiple Sclerosis

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Multiple Sclerosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06444113. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.