RECRUITING

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent

Conditions

Multiple Sclerosis MS PASS Post-Authorization Safety Study Mayzent Siponimod Pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study

Quick Facts

Study Start:2021-12-15

Study Completion:2032-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04933552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. 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 4. 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 1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. May or may not have taken another medication for MS in the current pregnancy 4. 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 1. Pregnant women 2. 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	1. Women who have enrolled in the siponimod cohort study with a previous pregnancy 2. Women who have used siponimod for an indication other than a currently approved indication 3. Women with exposure to any of the following medications within 5 half-lives prior to conception: * Cladribine (Mavenclad) * 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. 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. 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. 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 2. 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. 3. Women who have enrolled in the siponimod cohort or OMB157G2403 Kesimpta cohort with a previous pregnancy 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. 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. 1. 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 2. Women who have a diagnosis of a MS or a siponimod approved indication 3. Women who have a current diagnosis of any autoimmune disease 4. Women who have first contact with the project after prenatal diagnosis of any major structural defect 5. Women who have enrolled in the siponimod cohort or Kesimpta cohort study with a previous pregnancy 6. Women treated with Mayzent or Kesimpta for non-MS indication 7. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 8. 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. 9. Women exposed to a known human teratogen during pregnancy as confirmed by the OTIS Research Center

Inclusion Criteria

Exclusion Criteria

1. Pregnant women
2. Diagnosed with MS, with the indication validated by medical records when possible
3. 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
4. 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
1. Pregnant women
2. Diagnosed with MS, with the indication validated by medical records when possible
3. May or may not have taken another medication for MS in the current pregnancy
4. 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
1. Pregnant women
2. 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

1. Women who have enrolled in the siponimod cohort study with a previous pregnancy
2. Women who have used siponimod for an indication other than a currently approved indication
3. Women with exposure to any of the following medications within 5 half-lives prior to conception:
* Cladribine (Mavenclad)
* 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.
4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
5. 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.
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
2. 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.
3. Women who have enrolled in the siponimod cohort or OMB157G2403 Kesimpta cohort with a previous pregnancy
4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
5. 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.
1. 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
2. Women who have a diagnosis of a MS or a siponimod approved indication
3. Women who have a current diagnosis of any autoimmune disease
4. Women who have first contact with the project after prenatal diagnosis of any major structural defect
5. Women who have enrolled in the siponimod cohort or Kesimpta cohort study with a previous pregnancy
6. Women treated with Mayzent or Kesimpta for non-MS indication
7. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
8. 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.
9. Women exposed to a known human teratogen during pregnancy as confirmed by the OTIS Research Center

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Diana Johnson

CONTACT

1-877-311-8972

mothertobaby@health.ucsd.edu

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Novartis Investigative Site

La Jolla, California, 92093-0934

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-15

Study Completion Date2032-05-31

Study Record Updates

Study Start Date2021-12-15

Study Completion Date2032-05-31

Terms related to this study

Keywords Provided by Researchers

Multiple Sclerosis
MS
PASS
Post-Authorization Safety Study
Mayzent
Siponimod
Pregnancy

Additional Relevant MeSH Terms

Multiple Sclerosis