Multiple SclerosisNCT06940323
Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome, NMOSD
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to Jun 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Adult women diagnosed with multiple sclerosis (MS), clinically isolated syndrome (CIS), Neuromyelitis optica spectrum disorder (NMOSD), and/or myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.
Who may be able to join
- Pregnant or contemplating pregnancy
- Female, aged 18 to 64 years
- Diagnosis of one of the following conditions:
- Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Inflammatory Bowel Disease (IBD)
Show all 12Show fewer
- Rheumatoid Arthritis (RA)
- Myasthenia Gravis
- Lupus
- Other chronic neurological conditions
- Willing to provide biosamples and/or complete surveys at specified timepoints
- Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group)
Who cannot join
- Unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California-San Francisco
San Francisco, California, 94158
Min Ji Kim, 415-502-7209, minji.kim3@ucsf.edu
Ayushi Balan, 415-514-8330, ayushi.balan@ucsf.edu
About this study
Official title: Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions
PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally.
Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment.
Read more
By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta.
This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient.
The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.
Read the detailed description
The aim of this project is to develop a repository of samples for women who are pregnant and have chronic conditions, including demyelinating diseases -- either multiple sclerosis (MS), clinically isolated syndrome (CIS) or NMOSD (neuromyelitis optica spectrum disorders), chronic inflammation --- inflammatory bowel disease (IBD), rheumatoid arthritis (RA), lupus, myasthenia gravis (MG), primary headache disorders, or other chronic neurological conditions. Please note that the investigators refer to "MS" in the rest of the application.
This repository will include:
- Maternal Outcomes (disease-related outcomes, depression, social support, breastfeeding and pregnancy-related outcomes):
- Obtained via interviews, surveys, and medical record review during pregnancy planning, pregnancy (Baseline and 36w gestation) and postpartum (1, 4, 8, 12M)
- Maternal radiographic information will be collected from data available in the medical records. [Radiographic information will be information captured from the medical record, not obtained during the study visits. No radiology exams will be conducted as part of this research study. If deemed necessary for the subject's routine clinical care, the investigators will record the results of an MRI within 12M postpartum.]
- Infant Outcomes (growth, development, immunization, infection, breastfeeding, etc.)
- Obtained via medical record review (up to 12M)
- Monitored via maternal completion of the Ages and Stages Questionnaires-Version 3 (ASQ3) to track infant development outcomes (communication, gross motor, fine motor, problem solving, and person-social) at 2, 4, 6, 8, 10, and 12M of age.
- Biospecimen Collection, Storage \& Later Batch Analysis:
- Maternal blood samples will be collected for up to the following time points: Baseline (including if planning pregnancy), 3M gestation, 6M gestation, 8M gestation, 1M postpartum, 3M postpartum, and 6M postpartum. Samples will be processed and stored as serum, plasma and peripheral blood mononuclear cells (PBMCs).
- Serial breastmilk samples will be collected, for both before and after treatment if applicable, and up to 2-3 years postpartum. These samples will be used to determine the concentrations of medications in breastmilk relative to maternal serum.
- Serial maternal and infant gut microbiome samples will be collected before and after treatment (anytime during the lactation period which can extend up to 2-3 years postpartum) to determine the effect of mAb treatment on gut microbial populations in mothers and infants. Mothers will be asked to complete food frequency questionnaires for themselves and their infants at the time of each sample collection.
- Maternal vaginal swab sample will be collected in their 36 weeks of gestation (OR 8M pregnancy) to determine the effect of mAb treatment on vaginal microbial populations in mothers. Mothers will be asked to complete questionnaires regarding their diet and medication for themselves at the time of each sample collection.
- Serial maternal blood samples will be collected (including before and post treatment) anytime up to 2-3 years postpartum. These samples will be used to determine concentrations of medications in breastmilk relative to serum and to determine the effect of maternal treatment on mother and infant gut microbiome.
- Timing of sample collection for participants treated with mAb will depend on the treatment type, dosing and infusion schedule.
Participants who are healthy controls or who are not receiving specific medications of interest will provide
- A single breastmilk sample at 2M, 3M, and 4M
- A maternal and infant gut microbiome sample at 2M, 3M, and 4M postpartum
- Maternal vaginal swab sample at 36 weeks of gestation (OR 8M pregnancy).
- Maternal blood samples will be collected at corresponding timepoints 2M, 3M and 4M postpartum (to be processed and stored as serum, plasma, and PBMCs)
- Medical subject headings
- Multiple Sclerosis, Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy adult women who are planning pregnancy, currently pregnant, or postpartum. | |
| Multiple sclerosis (MS) | Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum. | |
| Clinically isolated syndrome (CIS) | Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum. | |
| Neuromyelitis optica spectrum disorder (NMOSD) | Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum. | |
| Myasthenia gravis | Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)
Changes in maternal disease activity will be assessed using the Expanded Disability Status Scale (EDSS) for individuals with multiple sclerosis (scored from 0 to 10, with higher scores indicating greater disability). Data will be collected via medical record review and participant self-report questionnaires.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI Findings
Changes in maternal disease activity will be assessed using magnetic resonance imaging (MRI) findings, including gadolinium-enhancing lesions, new or enlarging T2 lesions, and brain atrophy. Data will be collected via medical record review.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) Use
The maternal disease treatment course will be evaluated through an assessment of Disease Modifying Therapy (DMT) used pre-pregnancy to postpartum. This includes the specific type of DMT used in the pre-pregnancy period, any modifications or discontinuation of therapy during pregnancy, and the resumption or initiation of DMTs in the postpartum period. Data will be obtained through medical record review.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse Rates
Changes in maternal disease activity will be assessed using the clinical relapse rate. Relapses will be identified based on medical record review and participant self-report questionnaires administered at regular intervals. Additional information, such as the timing, severity, and treatment of relapses, will be collected when available.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Secondary outcomes (14)
Infant Growth and Development Outcomes Assessed by Chart Review and ASQ-3
Infant growth data (weight, length, head circumference) will be extracted from routine clinical records from Well-Child Care Visits up to 12 months. Developmental milestones will be assessed using the Ages and Stages Questionnaire, Version 3 (ASQ-3), administered at 2, 4, 6, 8, 10, and 12 months postpartum. ASQ-3 scores are age-specific and help assess infant communication, motor, problem-solving, and social-emotional development. Higher scores generally indicate better developmental progress.
Measured: From birth through 12 months postpartum
Detection and Concentration of Monoclonal Antibodies in Breastmilk
Breastmilk samples will be collected following postpartum infusions of anti-B cell therapies (e.g., ocrelizumab, rituximab), natalizumab, or monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor. Samples will be collected across 6 timepoints around the first postpartum infusion (pre-infusion; 7 days, 20 days, 30 days, 60 days, and 90 days post-infusion). Samples will be analyzed to detect the presence and concentration of these therapies in breastmilk and predict the relative transfer of medication to infants through breastmilk. Information about breastfeeding behavior including whether participants are exclusively breastfeeding, mixed feeding, or using formula, will be self-reported through accompanying survey or collected through chart review.
Measured: From first infusion postpartum through 12 months postpartum
Concentration of Monoclonal Antibodies and Disease-Related Biomarkers in Maternal Blood
Maternal blood samples will be collected at various time points: during the planning stage, at 8 months of pregnancy, and during the postpartum period (1, 2, 4, and 6 months postpartum), depending on the participant's ability and willingness to provide a sample. During the postpartum period, a set of blood samples will also be collected pre-infusion, and at 30 and 60 days post-infusion, either separately or in conjunction with other postpartum time points. These samples will be analyzed to determine serum drug levels for pharmacokinetic evaluation, as well as to assess other biomarkers of interest.
Measured: From the planning pregnancy (if applicable) to 6 months postpartum
Maternal Fatigue During Pregnancy and Postpartum Assessed by Modified Fatigue Impact Scale (MFIS)
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), which evaluates the perceived impact of fatigue on cognitive, physical, and psychosocial functioning. Scores range from 0 to 84. Higher scores indicate greater fatigue impact. This will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Medical Outcomes Study Sleep Scale (MOS-SS)
Sleep quality will be measured using the Medical Outcomes Study Sleep Scale (MOS-SS), which evaluates multiple dimensions of sleep such as sleep disturbance, snoring, and sleep adequacy. Scores are standardized, with higher scores generally indicating worse sleep quality, depending on the subscale. The survey will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Epworth-Sleepiness Scale (ESS)
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), a self-administered questionnaire that measures the general level of daytime sleepiness. The scale includes 8 items with scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness. The survey will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Cognitive Function During Pregnancy and Postpartum Assessed by Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
The Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) will be used to assess cognitive function and neuropsychological symptoms related to multiple sclerosis (MS). This self-reported questionnaire includes multiple domains such as memory, attention, and executive function, to evaluate the cognitive impact of MS during pregnancy and postpartum. Higher scores indicate more cognitive difficulty. This will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Social Support During Pregnancy and Postpartum Assessed by Medical Outcomes Study Social Support Survey (19-Item Version)
The Medical Outcomes Study Social Support Survey (19-Item Version) will assess the level of social support participants feel they have during pregnancy and postpartum. The survey includes items related to emotional, informational, and tangible support. Responses are scored on a 5-point Likert scale, with higher scores indicating greater perceived social support. This will be collected at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Hospital Anxiety and Depression Scale (HADS)
Maternal mood and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item scale with subscales for anxiety and depression, each scored from 0 to 21. Higher scores indicate greater symptom severity. The questionnaire will be administered at baseline (pre-pregnancy or early pregnancy), 36 weeks/8 months gestation, and at 1, 4, 8, and 12 months postpartum.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Edinburgh Postnatal Depression Scale (EPDS)
Maternal mood and depression symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item scale scored from 0 to 30. Higher scores indicate more severe postpartum depression symptoms. The questionnaire will be administered at baseline (pre-pregnancy or early pregnancy), 36 weeks/8 months gestation, and at 1, 4, 8, and 12 months postpartum.
Measured: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Mini International Neuropsychiatric Interview (MINI)
Maternal mood and depression symptoms will be assessed using Mini International Neuropsychiatric Interview (MINI), a structured diagnostic tool for mental health disorders. The interview includes specific questions and sections designed to assess the presence and severity of depressive symptoms. The questionnaire will be administered through a phone call for a short duration of around 15 minutes at 12 months postpartum.
Measured: 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Structured Clinical Interview for DSM-5 (SCID)
Maternal mood and depression symptoms will be assessed using the Structured Clinical Interview for DSM-5 (SCID), a semi-structured interview to make diagnoses according to the DSM-5 criteria. The questionnaire will be administered at 12 months postpartum by the study clinician.
Measured: 12 months postpartum
Maternal Bonding with Infant Assessed by Mother-to-Infant Bonding Scale (MIBS)
Maternal emotional bonding with the infant will be assessed using the Mother-to-Infant Bonding Scale (MIBS), a self-administered questionnaire designed to screen for potential bonding disorders in the postpartum period. The MIBS consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater difficulties in mother-infant bonding. The questionnaire will be administered during the postpartum period at 1, 4, 8, and 12 months.
Measured: From 1 month through 12 months postpartum
Infant Feeding Practices Assessed by Breastfeeding Questionnaire
Infant feeding practices will be assessed using a self-administered Breastfeeding Questionnaire, which captures detailed information on breastfeeding initiation, duration, frequency, exclusivity, and supplementation with formula or solid foods. The questionnaire also includes items addressing maternal perceptions, challenges, and reasons for changes in feeding practices. The questionnaire will be administered during the postpartum period at 1, 4, 8, and 12 months.
Measured: From 1 month through 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start21 Mar 2017
- Primary completionJun 2030 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940323
- Sponsor's protocol ID
- PRISMA
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson A, Krysko KM, Rutatangwa A, Krishnakumar T, Chen C, Rowles W, Zhao C, Houtchens MK, Bove R. Clinical and Radiologic Disease Activity in Pregnancy and Postpartum in MS. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 19;8(2):e959. doi: 10.1212/NXI.0000000000000959. Print 2021 Mar.
PubMed 33608303LaHue SC, Anderson A, Krysko KM, Rutatangwa A, Dorsey MJ, Hale T, Mahadevan U, Rogers EE, Rosenstein MG, Bove R. Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases. Neurol Neuroimmunol Neuroinflamm. 2020 May 27;7(4):e769. doi: 10.1212/NXI.0000000000000769. Print 2020 Jul.
PubMed 32461351Anderson A, Rowles W, Poole S, Balan A, Bevan C, Brandstadter R, Ciplea AI, Cooper J, Fabian M, Hale TW, Jacobs D, Kakara M, Krysko KM, Longbrake EE, Marcus J, Repovic P, Riley CS, Romeo AR, Rutatangwa A, West T, Hellwig K, LaHue SC, Bove R. Anti-CD20 monoclonal antibody therapy in postpartum women with neurological conditions. Ann Clin Transl Neurol. 2023 Nov;10(11):2053-2064. doi: 10.1002/acn3.51893. Epub 2023 Sep 7.
PubMed 37675826
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions
- ClinicalTrials.gov ID
- NCT06940323
- Acronym / sponsor ID
- PRISMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally.
Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment.
By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta.
This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient.
The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.
Detailed description
The aim of this project is to develop a repository of samples for women who are pregnant and have chronic conditions, including demyelinating diseases -- either multiple sclerosis (MS), clinically isolated syndrome (CIS) or NMOSD (neuromyelitis optica spectrum disorders), chronic inflammation --- inflammatory bowel disease (IBD), rheumatoid arthritis (RA), lupus, myasthenia gravis (MG), primary headache disorders, or other chronic neurological conditions. Please note that the investigators refer to "MS" in the rest of the application.
This repository will include:
- Maternal Outcomes (disease-related outcomes, depression, social support, breastfeeding and pregnancy-related outcomes):
- Obtained via interviews, surveys, and medical record review during pregnancy planning, pregnancy (Baseline and 36w gestation) and postpartum (1, 4, 8, 12M)
- Maternal radiographic information will be collected from data available in the medical records. [Radiographic information will be information captured from the medical record, not obtained during the study visits. No radiology exams will be conducted as part of this research study. If deemed necessary for the subject's routine clinical care, the investigators will record the results of an MRI within 12M postpartum.]
- Infant Outcomes (growth, development, immunization, infection, breastfeeding, etc.)
- Obtained via medical record review (up to 12M)
- Monitored via maternal completion of the Ages and Stages Questionnaires-Version 3 (ASQ3) to track infant development outcomes (communication, gross motor, fine motor, problem solving, and person-social) at 2, 4, 6, 8, 10, and 12M of age.
- Biospecimen Collection, Storage \& Later Batch Analysis:
- Maternal blood samples will be collected for up to the following time points: Baseline (including if planning pregnancy), 3M gestation, 6M gestation, 8M gestation, 1M postpartum, 3M postpartum, and 6M postpartum. Samples will be processed and stored as serum, plasma and peripheral blood mononuclear cells (PBMCs).
- Serial breastmilk samples will be collected, for both before and after treatment if applicable, and up to 2-3 years postpartum. These samples will be used to determine the concentrations of medications in breastmilk relative to maternal serum.
- Serial maternal and infant gut microbiome samples will be collected before and after treatment (anytime during the lactation period which can extend up to 2-3 years postpartum) to determine the effect of mAb treatment on gut microbial populations in mothers and infants. Mothers will be asked to complete food frequency questionnaires for themselves and their infants at the time of each sample collection.
- Maternal vaginal swab sample will be collected in their 36 weeks of gestation (OR 8M pregnancy) to determine the effect of mAb treatment on vaginal microbial populations in mothers. Mothers will be asked to complete questionnaires regarding their diet and medication for themselves at the time of each sample collection.
- Serial maternal blood samples will be collected (including before and post treatment) anytime up to 2-3 years postpartum. These samples will be used to determine concentrations of medications in breastmilk relative to serum and to determine the effect of maternal treatment on mother and infant gut microbiome.
- Timing of sample collection for participants treated with mAb will depend on the treatment type, dosing and infusion schedule.
Participants who are healthy controls or who are not receiving specific medications of interest will provide
- A single breastmilk sample at 2M, 3M, and 4M
- A maternal and infant gut microbiome sample at 2M, 3M, and 4M postpartum
- Maternal vaginal swab sample at 36 weeks of gestation (OR 8M pregnancy).
- Maternal blood samples will be collected at corresponding timepoints 2M, 3M and 4M postpartum (to be processed and stored as serum, plasma, and PBMCs)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Healthy adult women who are planning pregnancy, currently pregnant, or postpartum. |
| Multiple sclerosis (MS) | – | –Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum. |
| Clinically isolated syndrome (CIS) | – | –Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum. |
| Neuromyelitis optica spectrum disorder (NMOSD) | – | –Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum. |
| Myasthenia gravis | – | –Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult women diagnosed with multiple sclerosis (MS), clinically isolated syndrome (CIS), Neuromyelitis optica spectrum disorder (NMOSD), and/or myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.
Key inclusion criteria (12 listed)
- Pregnant or contemplating pregnancy
- Female, aged 18 to 64 years
- Diagnosis of one of the following conditions:
- Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
Key exclusion criteria (1 listed)
- Unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using the Expanded Disability Status Scale (EDSS) for individuals with multiple sclerosis (scored from 0 to 10, with higher scores indicating greater disability). Data will be collected via medical record review and participant self-report questionnaires.
Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI Findings
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using magnetic resonance imaging (MRI) findings, including gadolinium-enhancing lesions, new or enlarging T2 lesions, and brain atrophy. Data will be collected via medical record review.
Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) Use
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
The maternal disease treatment course will be evaluated through an assessment of Disease Modifying Therapy (DMT) used pre-pregnancy to postpartum. This includes the specific type of DMT used in the pre-pregnancy period, any modifications or discontinuation of therapy during pregnancy, and the resumption or initiation of DMTs in the postpartum period. Data will be obtained through medical record review.
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse Rates
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using the clinical relapse rate. Relapses will be identified based on medical record review and participant self-report questionnaires administered at regular intervals. Additional information, such as the timing, severity, and treatment of relapses, will be collected when available.
14 secondary outcomes
Infant Growth and Development Outcomes Assessed by Chart Review and ASQ-3
Time frame: From birth through 12 months postpartum
Detection and Concentration of Monoclonal Antibodies in Breastmilk
Time frame: From first infusion postpartum through 12 months postpartum
Concentration of Monoclonal Antibodies and Disease-Related Biomarkers in Maternal Blood
Time frame: From the planning pregnancy (if applicable) to 6 months postpartum
Maternal Fatigue During Pregnancy and Postpartum Assessed by Modified Fatigue Impact Scale (MFIS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Medical Outcomes Study Sleep Scale (MOS-SS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Epworth-Sleepiness Scale (ESS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Cognitive Function During Pregnancy and Postpartum Assessed by Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Social Support During Pregnancy and Postpartum Assessed by Medical Outcomes Study Social Support Survey (19-Item Version)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Edinburgh Postnatal Depression Scale (EPDS)
Time frame: From pre-pregnancy (if applicable) through 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Mini International Neuropsychiatric Interview (MINI)
Time frame: 12 months postpartum
Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Structured Clinical Interview for DSM-5 (SCID)
Time frame: 12 months postpartum
Maternal Bonding with Infant Assessed by Mother-to-Infant Bonding Scale (MIBS)
Time frame: From 1 month through 12 months postpartum
Infant Feeding Practices Assessed by Breastfeeding Questionnaire
Time frame: From 1 month through 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 33608303Anderson A, Krysko KM, Rutatangwa A, Krishnakumar T, Chen C, Rowles W, Zhao C, Houtchens MK, Bove R. Clinical and Radiologic Disease Activity in Pregnancy and Postpartum in MS. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 19;8(2):e959. doi: 10.1212/NXI.0000000000000959. Print 2021 Mar.
- Background: PubMed 32461351LaHue SC, Anderson A, Krysko KM, Rutatangwa A, Dorsey MJ, Hale T, Mahadevan U, Rogers EE, Rosenstein MG, Bove R. Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases. Neurol Neuroimmunol Neuroinflamm. 2020 May 27;7(4):e769. doi: 10.1212/NXI.0000000000000769. Print 2020 Jul.
- Results publication: PubMed 37675826Anderson A, Rowles W, Poole S, Balan A, Bevan C, Brandstadter R, Ciplea AI, Cooper J, Fabian M, Hale TW, Jacobs D, Kakara M, Krysko KM, Longbrake EE, Marcus J, Repovic P, Riley CS, Romeo AR, Rutatangwa A, West T, Hellwig K, LaHue SC, Bove R. Anti-CD20 monoclonal antibody therapy in postpartum women with neurological conditions. Ann Clin Transl Neurol. 2023 Nov;10(11):2053-2064. doi: 10.1002/acn3.51893. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riley Bove, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Ji Kim Kim, BA (415-502-7209, minji.kim3@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS) (time frame: From pre-pregnancy (if applicable) through 12 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.