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Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

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ClinicalTrials.gov Identifier: NCT02103361
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
Janssen Biotech, Inc.
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego

Brief Summary:
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Condition or disease Intervention/treatment
Psoriasis Pregnancy Psoriatic Arthritis Crohn Disease Drug: Ustekinumab Drug: Guselkumab

Detailed Description:
The purpose of the Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara or Tremfya within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Actual Study Start Date : November 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025


Group/Cohort Intervention/treatment
Stelara (ustekinumab) exposed
Stelara (ustekinumab)-exposed pregnant women
Drug: Ustekinumab
Other Name: Stelara

Tremfya (guselkumab) exposed
Tremfya (guselkumab-exposed pregnant women
Drug: Guselkumab
Other Name: Tremfya




Primary Outcome Measures :
  1. Major structural malformations [ Time Frame: From 3 months prior to the first day of the last menstrual period and up to one year of age ]
    The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects.


Secondary Outcome Measures :
  1. Minor Congenital Structural Malformations [ Time Frame: At dysmorphological exam which will occur at one time point between birth and one year of age ]
    One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations.


Other Outcome Measures:
  1. Spontaneous abortions [ Time Frame: From 3 months prior to the first day of the last menstrual period until the day of delivery ]
    Rate of spontaneous abortions

  2. Infant follow-up, growth [ Time Frame: Birth to one year of age ]
    Pre- and post-natal fetal and infant growth, small for gestational age, and preterm delivery

  3. Stillbirths [ Time Frame: From 3 months prior to the first day of the last menstrual period until the day of delivery ]
    Rate of stillbirth

  4. Infant follow-up, Immune system development [ Time Frame: Birth to 1 year of age ]
    Health and development including effects to the immune system development.

  5. Preterm delivery [ Time Frame: Birth ]
    Rate of preterm delivery



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women who have had exposure to Stelara (ustekinumab) or Tremfya (guselkumab) within 3 months of the last menstrual period, or anytime during pregnancy, and who reside in the U.S. or Canada.
Criteria

Inclusion Criteria:

  • Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy.
  • Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)

Exclusion Criteria:

  • Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103361


Contacts
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Contact: Diana Johnson, MS 877-311-8972 d4johnson@ucsd.edu
Contact: Christina Chambers, PhD, MPH 877-311-8972 chchambers@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Johnson         
Principal Investigator: Christina Chambers, PhD, MPH         
Sponsors and Collaborators
University of California, San Diego
The Organization of Teratology Information Specialists
Janssen Biotech, Inc.
Investigators
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Principal Investigator: Christina Chambers, PhD, MPH University of California, San Diego
Additional Information:
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Responsible Party: Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02103361    
Other Study ID Numbers: CNTO1275PSO4037
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Chambers, University of California, San Diego:
autoimmune disease
pregnancy
psoriasis
Stelara
ustekinumab
birth outcome
malformation
birth defect
psoriatic arthritis
Crohn's Disease
Tremfya
guselkumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Crohn Disease
Psoriasis
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Immune System Diseases
Ustekinumab
Dermatologic Agents