Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Cohort 1 – Kesimpta-Exposed Group:

• Women who are currently pregnant
• Women who have been diagnosed with Multiple Sclerosis (MS), confirmed by medical records where possible
• Women who received the MS medication Kesimpta either from about 166 days before their last menstrual period, or at any point during their pregnancy
• Women who agree to all study requirements, including scheduled interviews, sharing medical records, a physical examination of their newborn (if applicable), and completing a child development questionnaire

Cohort 2 – MS Comparison Group:

• Women who are currently pregnant
• Women who have been diagnosed with MS, confirmed by medical records where possible
• Women who may or may not have taken other MS medications during this pregnancy (but not Kesimpta)
• Women who agree to all study requirements, including scheduled interviews, sharing medical records, a physical examination of their newborn (if applicable), and completing a child development questionnaire

Cohort 3 – Healthy Comparison Group (sub-study only):

• Women who are currently pregnant
• Women who agree to all study requirements, including scheduled interviews, sharing medical records, a physical examination of their newborn (if applicable), and completing a child development questionnaire

Who may not be able to join:

Cohort 1 – Kesimpta-Exposed Group:

• Women who previously enrolled in this Kesimpta study during an earlier pregnancy
• Women who used Kesimpta for a reason other than an officially approved medical use
• Women who were exposed to certain other MS medications close to the time of conception, including other anti-CD20 antibody medications (same drug class as Kesimpta), S1P modulator medications (same drug class as Mayzent), Cladribine (Mavenclad), or Teriflunomide (Aubagio) — newer MS medications approved after 2021 will be assessed on a case-by-case basis as the study progresses (confirm with trial site)
• Women who have already had their pregnancy end before enrolling in the study
• Women whose prenatal tests have already confirmed a major structural birth defect in the baby — women with other prenatal test results, whether normal or showing other findings, may still be considered as long as no major structural defect has been confirmed

Cohort 2 – MS Comparison Group:

• Women who received Kesimpta from around 166 days before their last menstrual period or at any point during the current pregnancy
• Women who were exposed close to conception to certain MS medications, including anti-CD20 antibody drugs, Cladribine (Mavenclad), S1P modulator drugs, or Teriflunomide (Aubagio) — newer MS medications approved after 2021 will be assessed as the study progresses (confirm with trial site)
• Women who previously enrolled in this Kesimpta study or the related Mayzent (BAF312A2403) study during an earlier pregnancy
• Women who have already had their pregnancy end before enrolling in the study
• Women whose prenatal tests have already confirmed a major structural birth defect in the baby — women with other prenatal test results, whether normal or showing other findings, may still be considered as long as no major structural defect has been confirmed

Cohort 3 – Healthy Comparison Group (sub-study only):

• Women who received Kesimpta from around 166 days before their last menstrual period, or Mayzent from 4 days after their last menstrual period, or either medication at any point during the current pregnancy
• Women who have a diagnosis of MS
• Women who have a current diagnosis of any autoimmune disease
• Women who first contacted the study team after a prenatal diagnosis of a major structural birth defect was made
• Women who used Mayzent or Kesimpta for a reason other than treating MS
• Women who have already had their pregnancy end before enrolling in the study
• Women whose prenatal tests have already confirmed a major structural birth defect in the baby — women with other prenatal test results, whether normal or showing other findings, may still be considered as long as no major structural defect has been confirmed
• Women who were exposed during pregnancy to any medication known to cause birth defects in humans

Important: Always verify eligibility with the trial site directly before applying.