PsoriasisNCT02103361
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
An observational study of Psoriasis and Pregnancy, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Psoriasis, Pregnancy, Psoriatic Arthritis
- What is being tested?
- Ustekinumab and Guselkumab
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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. The Stelara (ustekinumab) exposed group completed enrollment as of September 2019. The Tremfya (guselkumab) remains open to recruitment.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Johnson
Christina Chambers, PhD, MPH
About this study
Official title: Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
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.
Read the 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.
- Conditions
- Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease
- Being tested
- Ustekinumab, Guselkumab
- Keywords
- autoimmune disease, pregnancy, psoriasis, Stelara, ustekinumab, birth outcome, malformation, birth defect, psoriatic arthritis, Crohn's Disease, Tremfya, guselkumab
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Crohn Disease, Autoimmune Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
GuselkumabDrug
Also called Tremfya
| Study group | Role | What they receive |
|---|---|---|
| Stelara (ustekinumab) exposed | Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment) Receives: Drug: Ustekinumab | |
| Tremfya (guselkumab) exposed | Tremfya (guselkumab-exposed pregnant women Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major structural malformations
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.
Measured: From 3 months prior to the first day of the last menstrual period and up to one year of age
Secondary outcomes (1)
Minor Congenital Structural Malformations
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.
Measured: At dysmorphological exam which will occur at one time point between birth and one year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- The Organization of Teratology Information Specialists, Janssen Biotech, Inc.
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
- Investigators
- Christina Chambers, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103361
- Sponsor's protocol ID
- CNTO1275PSO4037
- Status last verified
- Jan 2025
- First submitted
- 13 Feb 2014
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
- ClinicalTrials.gov ID
- NCT02103361
- Acronym / sponsor ID
- CNTO1275PSO4037
- Conditions
- Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease
- Keywords
- autoimmune disease, pregnancy, psoriasis, Stelara, ustekinumab, birth outcome, malformation, birth defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- The Organization of Teratology Information Specialists, Janssen Biotech, Inc.
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 3 Apr 2014 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stelara (ustekinumab) exposed | – | Drug: UstekinumabStelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment) |
| Tremfya (guselkumab) exposed | – | Drug: GuselkumabTremfya (guselkumab-exposed pregnant women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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. The Stelara (ustekinumab) exposed group completed enrollment as of September 2019. The Tremfya (guselkumab) remains open to recruitment.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| UstekinumabAlso: Stelara | Drug | Stelara (ustekinumab) exposed |
| GuselkumabAlso: Tremfya | Drug | Tremfya (guselkumab) exposed |
Primary outcome
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.
1 secondary outcome
Minor Congenital Structural Malformations
Time frame: At dysmorphological exam which will occur at one time point between birth and one year of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Official research website of the Organization of Teratology Information Specialists, Studies coordinated at the University of California, San DiegoLink provided by the sponsor.
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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.
Christina Chambers, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Pregnancy, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Johnson, MS (877-311-8972, d4johnson@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Jan 2025.