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

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

ClinicalTrials.gov Identifier: NCT04933552

Novartis Reference Number: CBAF312A2403

Last Update: Feb 03, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Start date 
Dec 15, 2021
Completion date 
May 31, 2032
Gender 
Female
Age(s)
(Child, Adult, Older Adult)

Interventions

Other
Siponimod
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.
Other
Siponimod
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.
Other
Siponimod
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.

Eligibility Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

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)
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
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) 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 study 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 siponimod any time from the 4th days 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 study 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.
Women exposed to a known human teratogen during pregnancy as confirmed by the OTIS Research Center

Study Locations

United States
Novartis Investigative Site
Recruiting
La Jolla, 92093-0934
California
United States
Novartis Investigative Site
Recruiting
La Jolla, 92093-0934
California
United States
Novartis Investigative Site
Recruiting
La Jolla, 92093-0934
California
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]