OTIS Autoimmune Diseases in Pregnancy Project
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| ClinicalTrials.gov Identifier: NCT01797224 |
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Recruitment Status :
Recruiting
First Posted : February 22, 2013
Last Update Posted : April 5, 2021
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Sponsor:
University of California, San Diego
Collaborators:
The Organization of Teratology Information Specialists
UCB Pharma
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego
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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 five years 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 |
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| Crohn's Disease Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis |
The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.
| Study Type : | Observational |
| Estimated Enrollment : | 925 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project |
| Study Start Date : | March 2012 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | October 2026 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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Cohort 1 - Exposed Cohort
Pregnant women with a current diagnosis of an approved indication who have used Cimzia (certolizumab pegol) in the first trimester of pregnancy for any length of time from the date of conception.
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Cohort 2 - Diseased Comparison Cohort
Pregnant women with a current diagnosis of a Cimzia approved indication who have not used Cimzia (certolizumab pegol) during the current pregnancy.
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Cohort 3 - Non-Diseased Comparison Cohort
Pregnant women without a current diagnosis of an autoimmune disease and who have not used Cimzia (certolizumab pegol) at any time in pregnancy, nor have they been exposed to any known human teratogen during pregnancy.
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Group 4 -Cimzia Registry, Not Qualified for the Cohort Study
Women who have used Cimzia (certolizumab pegol) 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.
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Primary Outcome Measures :
- Major malformations [ Time Frame: Duration of pregnancy and up to 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.
Secondary Outcome Measures :
- Minor malformations [ Time Frame: At dysmorphological exam which will occur at one time point between birth and 5 years 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.
- Pregnancy Outcome [ Time Frame: Duration of pregnancy and up to 1 year of life ]Another 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
- Infant follow-up [ Time Frame: Duration of pregnancy and up to 5 years of life ]Pre- and post-natal fetal and infant growth, health and development
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
Pregnant women who reside in the United States or Canada.
Criteria
Inclusion Criteria:
- Currently pregnant
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): NCT01797224
Contacts
| Contact: Diana Johnson, MS | 877-311-8972 | d4johnson@ucsd.edu | |
| Contact: Christina Chambers, MPH, PhD | 858-246-1740 | chchambers@ucsd.edu |
Locations
| United States, California | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92093 | |
| Contact: Diana Johnson, MS 877-311-8972 d4johnson@ucsd.edu | |
| Principal Investigator: Christina Chambers, MPH, PhD | |
Sponsors and Collaborators
University of California, San Diego
The Organization of Teratology Information Specialists
UCB Pharma
Investigators
| Principal Investigator: | Christina Chambers, PhD | University of California, San Diego |
Additional Information:
| Responsible Party: | Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01797224 |
| Other Study ID Numbers: |
RA0023 |
| First Posted: | February 22, 2013 Key Record Dates |
| Last Update Posted: | April 5, 2021 |
| Last Verified: | April 2021 |
Keywords provided by Christina Chambers, University of California, San Diego:
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Autoimmune disease certolizumab pegol Cimzia pregnancy |
birth defect birth outcome TNF Tumor necrosis factor |
Additional relevant MeSH terms:
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Spondylitis Arthritis Arthritis, Psoriatic Spondylitis, Ankylosing Crohn Disease Psoriasis Autoimmune Diseases Joint Diseases Musculoskeletal Diseases Immune System Diseases Skin Diseases, Papulosquamous Skin Diseases |
Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Bone Diseases, Infectious Infections Ankylosis |