OTIS Autoimmune Diseases in Pregnancy Project
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ClinicalTrials.gov Identifier: NCT01797224 |
Recruitment Status :
Recruiting
First Posted : February 22, 2013
Last Update Posted : April 5, 2021
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Condition or disease |
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Crohn's Disease Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis |
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 |

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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- 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.
- 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

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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 |
Inclusion Criteria:
- Currently pregnant

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
Contact: Diana Johnson, MS | 877-311-8972 | d4johnson@ucsd.edu | |
Contact: Christina Chambers, MPH, PhD | 858-246-1740 | chchambers@ucsd.edu |
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 |
Principal Investigator: | Christina Chambers, PhD | University of California, San Diego |
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 |
Autoimmune disease certolizumab pegol Cimzia pregnancy |
birth defect birth outcome TNF Tumor necrosis factor |
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 |