Multiple SclerosisNCT03198351
An Observational Study on Teriflunomide-exposed Pregnancies
An observational study of Multiple Sclerosis, run by Sanofi at 2 sites in 2 countries.
Trial summary
Primary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. Secondary Objective: To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Teriflunomide (HMR1726)
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Apr 2013to 13 Jun 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: -Pregnant women will be enrolled at various stages of gestation depending when they are included in the registry; then the pregnant outcome will be followed and for live infants, the follow up will be up to the children's 1 year birthday.
Who may be able to join
- Pregnant women who have provided an oral and/or written consent to enroll no later than 20 completed weeks from last menstrual period (LMP).
- Pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants (up to 1 year post birth).
- Pregnant women with a diagnosis of MS and teriflunomide exposure during pregnancy (Cohort 1).
- Pregnant women with MS but not exposed teriflunomide during pregnancy (Cohort 2).
- Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen during pregnancy (Cohort 3).
Who cannot join
- Pregnant women who come in first contact with the project after prenatal diagnosis of a major structural defect (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women who first come in contact with the project after 20 completed weeks' gestation (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women who had previously enrolled in the study for a previous pregnancy (only 1 pregnancy, per woman, maybe registered) (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Retrospectively reported cases (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women with exposures to teriflunomide commencing after the 12th week post-LMP (Cohort 1). This does not apply to the "registry" group.
- Pregnant women who had previously been treated with teriflunomide if they had received any dose of the drug within 2 years prior to the index pregnancy and do not have documented blood levels below 0.02 mcg/mL prior to pregnancy (Cohort 2).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California at San Diego-Site Number:001
San Diego, California, 92093
About this study
Official title: Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
Primary Objective:
To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
Secondary Objective:
To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.
Read the detailed description
The total study duration per participant is approximately up to 2 years.
- This is a prospective, observational study (no intervention), ie, patient registry.
- The statistical analysis for the cohort study describe baseline characteristics in all three cohorts, and then will compare pregnancy outcomes in cohort 1 to cohort 2 and secondarily to cohort 3.
- For the "registry" group, without comparisons, only descriptive statistics of pregnancy outcomes will be summarized.
- Conditions
- Multiple Sclerosis
- Being tested
- Teriflunomide (HMR1726)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriflunomide (HMR1726)Drug
Also called Aubagio
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy Receives: Drug: Teriflunomide (HMR1726) | |
| Cohort II | Pregnant women with MS not exposed to teriflunomide during the current pregnancy | |
| Cohort III | Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen | |
| "Registry" group (not eligible for cohorts) | Women who contact the OTIS registry study staff and who do not meet the criteria for the prospective study, for example, at time of contacting the study, having known prenatal diagnosis of congenital defect, or gestation weeks greater than 20 following a first trimester teriflunomide exposure, etc.; these participants will not be included in the primary analysis for the cohort study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major structural defects in live born infants
Measured: Up to the infant's first year birthday
Secondary outcomes (6)
Proportion of major structural defects in all pregnancies
Measured: up to 1 year of age in infant
Specific pattern of 3 or more minor structural defects in live born infants receiving the exam
Measured: up to one year after birth
Rate of spontaneous abortion
Measured: date of conception to 20 weeks gestation
Rate of preterm delivery
Measured: live birth prior to 37 weeks gestation
Proportion of infants who are small for gestational age (less than or equal to the 10th percentile for gestational age and sex) on weight, length, or head circumference
Measured: at birth
Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start25 Apr 2013
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
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 SanofiThe 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
- 220 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198351
- Sponsor's protocol ID
- OBS13499
- Other IDs
- U1111-1183-8711
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2017
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
- ClinicalTrials.gov ID
- NCT03198351
- Acronym / sponsor ID
- OBS13499
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2013 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 26 Jun 2017 (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.
Primary Objective:
To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
Secondary Objective:
To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.
Detailed description
The total study duration per participant is approximately up to 2 years.
- This is a prospective, observational study (no intervention), ie, patient registry.
- The statistical analysis for the cohort study describe baseline characteristics in all three cohorts, and then will compare pregnancy outcomes in cohort 1 to cohort 2 and secondarily to cohort 3.
- For the "registry" group, without comparisons, only descriptive statistics of pregnancy outcomes will be summarized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort I | – | Drug: Teriflunomide (HMR1726)Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy |
| Cohort II | – | –Pregnant women with MS not exposed to teriflunomide during the current pregnancy |
| Cohort III | – | –Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen |
| "Registry" group (not eligible for cohorts) | – | –Women who contact the OTIS registry study staff and who do not meet the criteria for the prospective study, for example, at time of contacting the study, having known prenatal diagnosis of congenital defect, or gestation weeks greater than 20 following a first trimester teriflunomide exposure, etc.; these participants will not be included in the primary analysis for the cohort study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Pregnant women will be enrolled at various stages of gestation depending when they are included in the registry; then the pregnant outcome will be followed and for live infants, the follow up will be up to the children's 1 year birthday.
Key inclusion criteria (5 listed)
- Pregnant women who have provided an oral and/or written consent to enroll no later than 20 completed weeks from last menstrual period (LMP).
- Pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants (up to 1 year post birth).
- Pregnant women with a diagnosis of MS and teriflunomide exposure during pregnancy (Cohort 1).
- Pregnant women with MS but not exposed teriflunomide during pregnancy (Cohort 2).
- Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen during pregnancy (Cohort 3).
Key exclusion criteria (7 listed)
- Pregnant women who come in first contact with the project after prenatal diagnosis of a major structural defect (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women who first come in contact with the project after 20 completed weeks' gestation (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women who had previously enrolled in the study for a previous pregnancy (only 1 pregnancy, per woman, maybe registered) (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Retrospectively reported cases (Cohort 1, 2, 3). This does not apply to the "registry" group.
- Pregnant women with exposures to teriflunomide commencing after the 12th week post-LMP (Cohort 1). This does not apply to the "registry" group.
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 |
|---|---|---|
| Teriflunomide (HMR1726)Also: AubagioPharmaceutical form: tablet Route of administration: oral | Drug | Cohort I |
Primary outcome
Rate of major structural defects in live born infants
Time frame: Up to the infant's first year birthday
6 secondary outcomes
Proportion of major structural defects in all pregnancies
Time frame: up to 1 year of age in infant
Specific pattern of 3 or more minor structural defects in live born infants receiving the exam
Time frame: up to one year after birth
Rate of spontaneous abortion
Time frame: date of conception to 20 weeks gestation
Rate of preterm delivery
Time frame: live birth prior to 37 weeks gestation
Proportion of infants who are small for gestational age (less than or equal to the 10th percentile for gestational age and sex) on weight, length, or head circumference
Time frame: at birth
Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
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. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Sanofi at 2 sites in 2 countries.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major structural defects in live born infants (time frame: Up to the infant's first year birthday). 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 28 Aug 2023.