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Trial record 11 of 564 for:    (woman OR women OR female) AND "Autoimmune Diseases"

Apremilast Pregnancy Exposure Registry

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ClinicalTrials.gov Identifier: NCT02775500
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Celgene
The Organization of Teratology Information Specialists
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego

Brief 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 year of age.

Condition or disease Intervention/treatment
Psoriatic Arthritis Psoriasis Drug: apremilast

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 Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Study Start Date : November 2014
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
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.
Drug: apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Other Name: Otezla

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.
Drug: apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Other Name: Otezla




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups [ Time Frame: At the end of pregnancy ]
    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.

  3. Gestational age at delivery among infants in the cohort groups [ Time Frame: At the end of pregnancy ]
    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.

  4. Pregnancy Complication rates between cohort groups [ Time Frame: From the first day of the last menstrual period (LMP) through delivery ]
    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.

  5. Neonatal Complication rates between cohort groups [ Time Frame: Birth of the child to 1 month of age. ]
    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.

  6. 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 ]
    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.

  7. 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 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.

  8. Any malignancies diagnosed in infants of mothers enrolled in the study [ Time Frame: Up to one year of age of the child ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Pregnant

Exclusion Criteria:


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): NCT02775500


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

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Diana Johnson, MS    877-311-8972    mothertobaby@ucsd.edu   
Principal Investigator: Christina Chambers, PhD, MPH         
Sponsors and Collaborators
University of California, San Diego
Celgene
The Organization of Teratology Information Specialists
Investigators
Principal Investigator: Christina Chambers, PhD, MPH UCSD

Responsible Party: Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02775500     History of Changes
Other Study ID Numbers: 141041
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christina Chambers, University of California, San Diego:
pregnancy
apremilast
Otezla
autoimmune disease
psoriatic arthritis
psoriasis
TNF
tumor necrosis factor
birth outcome
birth defect

Additional relevant MeSH terms:
Autoimmune Diseases
Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Immune System Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors