La Jolla, CANCT05634967Now EnrollingIRB Ready

Multiple Sclerosis Clinical Trial in La Jolla, CA

Access cutting-edge multiple sclerosis treatment through this clinical trial at a research site in La Jolla. Study-provided care at no cost to qualified participants.

Sponsored by Novartis Pharmaceuticals

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Expert Care in La Jolla

Access multiple sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related multiple sclerosis treatment provided free

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Check if you qualify for this multiple sclerosis clinical trial in La Jolla, CA

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Why Participate?

  • No-Cost Study Care

  • Local to La Jolla

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit La Jolla site if eligible
  4. 4Begin participation

About This Multiple Sclerosis Study in La Jolla

The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.

Sponsor: Novartis Pharmaceuticals

Who Can Participate

Inclusion Criteria

Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry: Cohort 1: Kesimpta-Exposed Cohort
Pregnant women
Diagnosed with MS, with the indication validated by medical records when possible
Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Pregnant women
Diagnosed with MS, with the indication validated by medical records when possible
May or may not have taken another medication for MS in the current pregnancy
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children Cohort 3: Healthy Comparison Cohort (Comparison Group 2):Kesimpta-OTIS sub-study specific
Pregnant women
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children

Exclusion Criteria

Women meeting any of the following criteria will be excluded from the cohort study: Cohort 1: Kesimpta-Exposed Cohort
Women who have enrolled in the Kesimpta cohort study with a previous pregnancy
Women who have used Kesimpta for an indication other than a currently approved indication
Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:
Other anti-CD20 monoclonal antibody: same class as Kesimpta
S1P modulators: same class as Mayzent
Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.
New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy
Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception:
Anti CD-20 monoclonal antibody
Cladribine (Mavenclad)
S1P modulators
Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy
Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. Cohort 3: Healthy Comparison Cohort (Comparison Group 2): Only applicable to Kesimpta-OTIS sub-study
Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy
Women who have a diagnosis of a MS
Women who have a current diagnosis of any autoimmune disease
Women who have first contact with the project after prenatal diagnosis of any major structural defect
Women treated with Mayzent or Kesimpta for non-MS indication
Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
Women exposed to a known human teratogenic drugs during pregnancy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in La Jolla?

Yes, this clinical trial (NCT05634967) has an active research site in La Jolla, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Multiple Sclerosis Treatment Options in La Jolla, CA

If you're searching for multiple sclerosis treatment options in La Jolla, CA, this clinical trial (NCT05634967) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

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