An Observational Study on Teriflunomide-exposed Pregnancies

• ClinicalTrials.gov Identifier: NCT03198351
• Recruitment Status: Recruiting
• First Posted: June 26, 2017
• Last Update Posted: January 9, 2023
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: June 22, 2017
• First Posted Date: June 26, 2017
• Last Update Posted Date: January 9, 2023
• Actual Study Start Date: April 25, 2013
• Estimated Primary Completion Date: July 3, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 22, 2017): Rate of major structural defects in live born infants [ Time Frame: Up to the infant's first year birthday ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 22, 2017)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Observational Study on Teriflunomide-exposed Pregnancies
• Official Title: Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

Brief 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 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• 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.
• Condition: Multiple Sclerosis

Intervention

Drug: Teriflunomide (HMR1726)

Pharmaceutical form: tablet

Route of administration: oral

Other Name: Aubagio

Study Groups/Cohorts

• Cohort I
  Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy
  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 22, 2017): 325
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 3, 2023
• Estimated Primary Completion Date: July 3, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria :

• 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).

Exclusion criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada); 800-633-1610 ext 1 then #; Contact-US@sanofi.com

• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03198351
• Other Study ID Numbers: OBS13499; U1111-1183-8711 ( Other Identifier: UTN )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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

• Current Responsible Party: Sanofi
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: January 2023