Psoriatic ArthritisNCT02775500
Apremilast Pregnancy Exposure Registry
An observational study of Psoriatic Arthritis and Psoriasis, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis, Psoriasis
- What is being tested?
- apremilast
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes pregnant women who reside in the U.S. or Canada. All exposed subjects and comparison subjects will be recruited through spontaneous callers to participating OTIS member services in locations throughout North America and through active recruitment strategies, e.g., direct mailings to rheumatologists, dermatologists and other relevant specialists, obstetric health care providers, pharmacists, web site, and professional meetings.
Who may be able to join
- Pregnant
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.
Read the detailed description
The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada.
The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age.
The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and the effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.
The Pregnancy Exposure Registry is sponsored by Celgene Corporation and is conducted by the Organization of Teratology Information Specialists (OTIS) Research Group and is administered by investigators at the coordinating site located at the University of California, San Diego. The study is planned for seven years.
- Conditions
- Psoriatic Arthritis, Psoriasis
- Being tested
- apremilast
- Keywords
- pregnancy, apremilast, Otezla, autoimmune disease, psoriatic arthritis, psoriasis, TNF, tumor necrosis factor, birth outcome, birth defect
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis, Autoimmune Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
Also called Otezla
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
| Study group | Role | What they receive |
|---|---|---|
| Apremilast-Exposed Cohort | Women who have been exposed to apremilast in pregnancy for an approved indication in the first trimester of pregnancy for any length of time from the date of conception. Receives: Drug: apremilast | |
| Diseased Comparison Cohort | Women with an approved disease who have not been exposed to apremilast at any time in pregnancy. | |
| Healthy Comparison Cohort | Healthy women who have no diagnosis of an approved indication or other chronic illness, have not taken apremilast in pregnancy, nor have they been exposed to any known human teratogen during pregnancy. | |
| Apremilast-Exposed Registry Group | Women who have been exposed to apremilast in pregnancy, for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study. Receives: Drug: apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of major structural malformations identified in the children of study participants
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 in children of study participants. The study is analyzing the difference in the number of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
Measured: Throughout pregnancy through 1 year of life
A pattern of major malformations identified in the children of study participants
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 a pattern of major malformations in children of study participants. The study is analyzing the difference in the pattern of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
Measured: Throughout pregnancy through 1 year of life
Secondary outcomes (8)
Pattern of minor structural malformations identified by study physical exam in the children of study participants
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 a potential pattern of minor malformations. Information collected during the dysmorphology exam.
Measured: Assessed when the dysmorphology exam is conducted, which will occur between birth of the child and through study completion, an average of 1 year of age
Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups
Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to pregnancy outcome (rates of live born infants, spontaneous abortions, stillbirths, and terminations. Information will be collected from maternal interview and through medical records.
Measured: At the end of pregnancy
Gestational age at delivery among infants in the cohort groups
Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to gestational age at delivery. Rates of preterm and full-term delivery between cohorts will be compared, as well as any statistical differences in gestational age at delivery. Information will be collected from maternal interview and through medical records.
Measured: At the end of pregnancy
Pregnancy Complication rates between cohort groups
Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to pregnancy complications. Rates of pregnancy complications between cohorts will be compared. Information will be collected from maternal interview and through medical records.
Measured: From the first day of the last menstrual period (LMP) through delivery
Neonatal Complication rates between cohort groups
Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to neonatal complications. Rates of neonatal complications between cohorts will be compared. Information will be collected from maternal interview and through medical records.
Measured: Birth of the child to 1 month of age.
Pre- and post-natal fetal and infant growth percentiles
Pre- and post-natal fetal and infant growth will be compared between cohorts. The study will analyze rates between cohorts for small for gestational age, those that are small for weight, length, and/or head circumference up to one year of age. Information will be collected from maternal interview and through medical records.
Measured: From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child
Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study
Any opportunistic or serious infection, including any infection requiring hospitalization in the child. Rates of infections will be compared between cohort groups. Information will be collected from maternal interview and through medical records.
Measured: Up to one year of age of the child
Any malignancies diagnosed in infants of mothers enrolled in the study
Any malignancy diagnosed in the child up to 1 year of age. Rate of malignancies will be compared between cohort groups. Information will be collected from maternal interview and through medical records.
Measured: Up to one year of age of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2024
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- 233 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, The Organization of Teratology Information Specialists
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
- Investigators
- Christina Chambers, PhD, MPH, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775500
- Sponsor's protocol ID
- 141041
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2016
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
- ClinicalTrials.gov ID
- NCT02775500
- Acronym / sponsor ID
- 141041
- Conditions
- Psoriatic Arthritis, Psoriasis
- Keywords
- pregnancy, apremilast, Otezla, autoimmune disease, psoriatic arthritis, psoriasis, TNF, tumor necrosis factor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Celgene, The Organization of Teratology Information Specialists
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 May 2016 (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 Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.
Detailed description
The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada.
The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age.
The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and the effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.
The Pregnancy Exposure Registry is sponsored by Celgene Corporation and is conducted by the Organization of Teratology Information Specialists (OTIS) Research Group and is administered by investigators at the coordinating site located at the University of California, San Diego. The study is planned for seven years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apremilast-Exposed Cohort | – | Drug: apremilastWomen who have been exposed to apremilast in pregnancy for an approved indication in the first trimester of pregnancy for any length of time from the date of conception. |
| Diseased Comparison Cohort | – | –Women with an approved disease who have not been exposed to apremilast at any time in pregnancy. |
| Healthy Comparison Cohort | – | –Healthy women who have no diagnosis of an approved indication or other chronic illness, have not taken apremilast in pregnancy, nor have they been exposed to any known human teratogen during pregnancy. |
| Apremilast-Exposed Registry Group | – | Drug: apremilastWomen who have been exposed to apremilast in pregnancy, for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes pregnant women who reside in the U.S. or Canada. All exposed subjects and comparison subjects will be recruited through spontaneous callers to participating OTIS member services in locations throughout North America and through active recruitment strategies, e.g., direct mailings to rheumatologists, dermatologists and other relevant specialists, obstetric health care providers, pharmacists, web site, and professional meetings.
Key inclusion criteria (1 listed)
- Pregnant
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| apremilastAlso: OtezlaComparison of women exposed during pregnancy versus women who are not exposed to apremilast | Drug | Apremilast-Exposed Cohort, Apremilast-Exposed Registry Group |
Primary outcome
The number of major structural malformations identified in the children of study participants
Time frame: Throughout pregnancy through 1 year of life
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 in children of study participants. The study is analyzing the difference in the number of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
A pattern of major malformations identified in the children of study participants
Time frame: Throughout pregnancy through 1 year of life
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 a pattern of major malformations in children of study participants. The study is analyzing the difference in the pattern of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
8 secondary outcomes
Pattern of minor structural malformations identified by study physical exam in the children of study participants
Time frame: Assessed when the dysmorphology exam is conducted, which will occur between birth of the child and through study completion, an average of 1 year of age
Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups
Time frame: At the end of pregnancy
Gestational age at delivery among infants in the cohort groups
Time frame: At the end of pregnancy
Pregnancy Complication rates between cohort groups
Time frame: From the first day of the last menstrual period (LMP) through delivery
Neonatal Complication rates between cohort groups
Time frame: Birth of the child to 1 month of age.
Pre- and post-natal fetal and infant growth percentiles
Time frame: From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child
Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study
Time frame: Up to one year of age of the child
Any malignancies diagnosed in infants of mothers enrolled in the study
Time frame: Up to one year of age of the child
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.
- Organization of Teratology Information Specialists and MotherToBaby website containing study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christina Chambers, PhD, MPH principal investigator
UCSD
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 Psoriatic Arthritis and Psoriasis, 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 1 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: under way, not looking for participants, 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?
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?
The number of major structural malformations identified in the children of study participants (time frame: Throughout pregnancy through 1 year of life). The study lists 2 primary outcomes in all. 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.