NCT04933552 · Novartis Pharmaceuticals
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
What this study is about
This study will utilize a forward-looking, observational, exposure group of participants design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
View original scientific 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.
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.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- La Jolla, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 16, 2024 · Source of record for eligibility and locations