Multiple SclerosisNCT04933552
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Siponimod
- How many people
- 867 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 31 May 2032
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes pregnant women who reside in the US or Canada.
Who may be able to join
- Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
- Cohort 1: Siponimod-Exposed Cohort
- Pregnant women
- Diagnosed with MS, with the indication validated by medical records when possible
- Exposure to siponimod for the treatment of MS, for any number of days, at any dose, and at any time from the 4th day post the first day of LMP prior to conception 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, and the Ages and Stages Questionnaire (ASQ) in live born children
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- 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, and the ASQ in live born children
- Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
- 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 the ASQ in live born children
Who cannot join
- Women meeting any of the following criteria will be excluded from the cohort study:
- Cohort 1: Siponimod-Exposed Cohort
- Women who have enrolled in the siponimod cohort study with a previous pregnancy
- Women who have used siponimod for an indication other than a currently approved indication
- Women with exposure to any of the following medications within 5 half-lives prior to conception:
- Cladribine (Mavenclad)
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- Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
- All other S1P modulators including fingolimod (Gilenya), ozanimod, etc.
- S1P modulatros are in the same class of drug as siponimod
- Teriflunomide (Aubagio)
- The teratogenicity of teriflunomide is unknown and currently under investigation
- Other anti-CD20 monoclonal antibody: same class as Kesimpta
- New medications (marketed after 2020) 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 a diagnostic test 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):
- Exposure to siponimod any time from the 4th day post the first day of LMP prior to conception up to and including end of pregnancy
- Women with exposure to any of the following medications within 5 half-lives of conception:
- Cladribine (Mavenclad)
- S1P modulators
- Teriflunomide (Aubagio)
- Anti CD-20 monoclonal antibody New medications (marketed after 2020) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
- Women who have enrolled in the siponimod cohort or OMB157G2403 Kesimpta 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 a diagnostic test 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):
- Exposure to Kesimpta 166 days before or to siponimod any time from the 4th day post first day of LMP prior to conception to and including end of pregnancy
- Women who have a diagnosis of a MS or a siponimod approved indication
- 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 who have enrolled in the siponimod cohort or Kesimpta cohort study with a previous pregnancy
- 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 a diagnostic test 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 teratogen during pregnancy as confirmed by the OTIS Research Center
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
Novartis Investigative Site
La Jolla, California, 92093-0934
About this study
Official title: Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
Read the detailed description
The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used siponimod during pregnancy but have been diagnosed with MS (disease-matched unexposed comparison group), and a comparison group of healthy women who do not have diagnosis of MS, have not had exposure to a known human teratogen, and have not taken siponimod in pregnancy (healthy comparison group). Pregnant women exposed to siponimod who do not meet the prospective cohort criteria will also be followed as part of an exposure series. All participants will be recruited via voluntary participant registration following informed consent by the pregnant woman for her participation. Participants may withdraw from the study at any time.
- Conditions
- Multiple Sclerosis
- Being tested
- Siponimod
- Keywords
- Multiple Sclerosis, MS, PASS, Post-Authorization Safety Study, Mayzent, Siponimod, Pregnancy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiponimodOther
Also called Mayzent
Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Siponimod-Exposed | Pregnant women with MS exposed to siponimod during pregnancy Receives: Other: Siponimod | |
| Disease-Matched Comparison | Pregnant women with MS not exposed to siponimod during pregnancy | |
| Healthy Comparison | Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of major structural defects
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (e.g., a cleft lip).
Measured: Up to 10,5 years
Secondary outcomes (10)
Number of spontaneous abortion/miscarriage
Spontaneous abortion/miscarriage is defined as non-deliberate fetal death which occurs prior to less than 20.0 weeks post-LMP.
Measured: Up to 10,5 years
Number of stillbirth
stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP.
Measured: Up to 10,5 years
Number of elective termination
elective termination/abortion is defined as deliberate termination of pregnancy at any time in gestation. Reasons for elective abortions are captured and are classified as due to medical reasons or social reasons.
Measured: Up to 10,5 years
Number of premature delivery
premature delivery is defined as live birth prior to 37.0 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if last menstrual period uncertain or more than 1 week discrepant). Elective caesarian deliveries or inductions prior to 37.0 completed weeks will be considered separately.
Measured: Up to 10,5 years
Number of preeclampsia / eclampsia
preeclampsia or eclampsia reported by maternal interview with confirmation in medical record or report by medical record only is captured.
Preeclampsia is defined as a new onset of hypertension and proteinuria during pregnancy or postpartum. Eclampsia is the new onset of seizures or coma in a pregnant woman with preeclampsia. These seizures are not related to an existing brain condition.
Measured: Up to 1 10,5 years
Pattern of 3 or more minor structural defects
A minor structural defect is defined as a defect which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). Minor structural defects will be identified only through the study dysmorphology examination for live born infants using the study-specific checklist.
Measured: Up to 10,5 years
Small for gestational age
small for gestational age is defined as birth size (weight, length or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants (CDC, 2000; Olsen et al., 2010).
Measured: Up to 10,5 years
Postnatal growth small for age at approximately one year of age
postnatal growth deficiency is defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than one year of age (CDC, 2000).
Measured: Up to 10,5 years
Developmental performance at approximately one year of age
Screening of Developmental Milestones: one or more domains scored as abnormal on the Ages and Stages Questionnaire completed by the mother when the infant is approximately one year of age will define achievement of developmental milestones.
Measured: Up to 10,5 years
Serious or opportunistic infections in the first year of life
serious or opportunistic infections are defined as any one or more diagnoses of tuberculosis, x-ray proven pneumonia, neonatal sepsis, meningitis, bacteremia, invasive fungal infection, pneumocysitis, septic arthritis, osteomyelitis, abcess (deep tissue), and infections requiring hospitalization identified in live born infants up to one year of age.
Measured: Up to 10,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Dec 2021
- Primary completion31 May 2032 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Prospective
- Enrolment
- 867 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933552
- Sponsor's protocol ID
- CBAF312A2403
- Status last verified
- May 2024
- First submitted
- 18 Jun 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study
- ClinicalTrials.gov ID
- NCT04933552
- Acronym / sponsor ID
- CBAF312A2403
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, PASS, Post-Authorization Safety Study, Mayzent, Siponimod, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 867 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 May 2032 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 21 Jun 2021 (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.
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
Detailed description
The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used siponimod during pregnancy but have been diagnosed with MS (disease-matched unexposed comparison group), and a comparison group of healthy women who do not have diagnosis of MS, have not had exposure to a known human teratogen, and have not taken siponimod in pregnancy (healthy comparison group). Pregnant women exposed to siponimod who do not meet the prospective cohort criteria will also be followed as part of an exposure series. All participants will be recruited via voluntary participant registration following informed consent by the pregnant woman for her participation. Participants may withdraw from the study at any time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Siponimod-Exposed | – | Other: SiponimodPregnant women with MS exposed to siponimod during pregnancy |
| Disease-Matched Comparison | – | –Pregnant women with MS not exposed to siponimod during pregnancy |
| Healthy Comparison | – | –Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes pregnant women who reside in the US or Canada.
Key inclusion criteria (14 listed)
- Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
- Cohort 1: Siponimod-Exposed Cohort
- Pregnant women
- Diagnosed with MS, with the indication validated by medical records when possible
- Exposure to siponimod for the treatment of MS, for any number of days, at any dose, and at any time from the 4th day post the first day of LMP prior to conception up to and including the end of pregnancy
Key exclusion criteria (35 listed)
- Cohort 1: Siponimod-Exposed Cohort
- Women who have enrolled in the siponimod cohort study with a previous pregnancy
- Women who have used siponimod for an indication other than a currently approved indication
- Women with exposure to any of the following medications within 5 half-lives prior to conception:
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SiponimodAlso: MayzentProspective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled. | Other | Siponimod-Exposed |
Primary outcome
Prevalence of major structural defects
Time frame: Up to 10,5 years
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (e.g., a cleft lip).
10 secondary outcomes
Number of spontaneous abortion/miscarriage
Time frame: Up to 10,5 years
Number of stillbirth
Time frame: Up to 10,5 years
Number of elective termination
Time frame: Up to 10,5 years
Number of premature delivery
Time frame: Up to 10,5 years
Number of preeclampsia / eclampsia
Time frame: Up to 1 10,5 years
Pattern of 3 or more minor structural defects
Time frame: Up to 10,5 years
Small for gestational age
Time frame: Up to 10,5 years
Postnatal growth small for age at approximately one year of age
Time frame: Up to 10,5 years
Developmental performance at approximately one year of age
Time frame: Up to 10,5 years
Serious or opportunistic infections in the first year of life
Time frame: Up to 10,5 years
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 16 May 2024.
- MotherToBaby Pregnancy Studies are observational studies coordinated at the University of California San Diego. Our studies are currently enrolling pregnant women in a study examining the use of medications to treat multiple sclerosis during pregnancy.Link provided by the sponsor.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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, run by Novartis Pharmaceuticals 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 14 inclusion and 35 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 16 May 2024. 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 Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of major structural defects (time frame: Up to 10,5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.