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NCT Number: NCT03992729

Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.

The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.

These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.

The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.

Recruiting

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Key information

Conditions

Pregnancy Related

Sex eligibility

Female

Study type

Observational

Primary location

Christina Chambers

San Diego, California, 92093, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Cohort 1: Tildrakizumab-Exposed Cohort

  • Pregnant women
  • Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy
  • Agree to the conditions and requirements of the study including the interview schedule, and release of medical records

Cohort 2: Disease-Matched Comparison Cohort

  • Pregnant women
  • Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
  • No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
  • Agree to the conditions and requirements of the study including the interview schedule, and release of medical records

Exclusion criteria

Cohort 1: Tildrakizumab-Exposed Cohort:

  • Women who have first contact with the project after prenatal diagnosis of any major structural defect
  • Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
  • Women who have used tildrakizumab for an indication other than a currently approved indication
  • Retrospective enrollment after the outcome of pregnancy is known

Cohort 2: Disease-Matched Comparison Cohort

  • Women who have first contact with the project after prenatal diagnosis of any major structural defect
  • Exposure to tildrakizumab anytime during the current pregnancy
  • Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
  • Retrospective enrollment after the outcome of pregnancy is known

Treatment and study plan

Pregnant women exposed to tildrakizumab

Drug

Subjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy

Pregnant women not exposed to tildrakizumab

Drug

Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy

Primary outcomes

  1. Major structural defects in children

    Time frame: Up to 1 year of age

    defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects

Secondary outcomes

  1. Spontaneous abortion/miscarriage

    Time frame: 20 weeks post-last menstrual period

    defined as non-deliberate fetal death that occurs prior to 20.0 weeks post-last menstrual period

  2. Stillbirth

    Time frame: from 20 weeks post-last menstrual period to end of pregnancy

    defined as non-deliberate fetal death anytime in gestation at or after 20.0 weeks post-last menstrual period

  3. Elective termination/abortion

    Time frame: At the end of pregnancy or through 9 month pregnancy period

    defined as deliberate discontinuation of pregnancy through medication or surgical procedures

  4. neonatal/infant death

    Time frame: 6 months of age

    defined as any death in a live born infant during the first 6 months of age

  5. Small for gestational age

    Time frame: at birth

    defined as birth size (weight, length, or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants

  6. Postnatal growth deficiency

    Time frame: Up to 1 year of age

    defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using standard pediatric growth curves and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age

  7. Malignancies in live born children

    Time frame: Up to 1 year of age

    defined as any malignancy reported in an infant within the first year of life

  8. Hospitalization in live born children

    Time frame: Up to 1 year of age

    defined as any hospitalization of the infant within the first year of life after discharge following delivery

  9. Postnatal serious or opportunistic infection in live born children

    Time frame: Up to 1 year

    defined as any infection resulting in hospitalization, X-ray proven pneumonia, neonatal sepsis, meningitis, osteomyelitis, bacteremia, septic arthritis, abscess, mycobacteria infections, invasive fungal infection including histoplasmosis, coccidiomycosis, candidiasis, aspergillosis, and blastomycosis, pneumocystis jirovecii infection, systemic cytomegalovirus, herpes zoster and herpes simplex infection, listeria infections, and Legionella infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Head, Clinical Development

CONTACT

[email protected]

91 2266455645 ext. 5689

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 20, 2019
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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