Suspended

Evaluation of Cimzia's Impact on Pregnancy and Child Development in Women with Autoimmune Diseases

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Study Aim

This study aims to observe the impact of a medication called Cimzia, used in the first trimester of pregnancy, on the occurrence of major structural birth defects in children born to women with autoimmune diseases.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Axial Spondyloarthritis+26

+ Ankylosis

+ Arthritis

1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorUniversity of California, San Diego
Last updated: January 28, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01797224
Principal SponsorUniversity of California, San Diego
Last updated: January 28, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

925 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Axial SpondyloarthritisAnkylosisArthritisBone DiseasesConnective Tissue DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesImmune System DiseasesIntestinal DiseasesJoint DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRheumatic DiseasesSkin DiseasesSpinal DiseasesSpondylitisInflammatory Bowel DiseasesSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathiesCongenital AbnormalitiesArthritis, RheumatoidAutoimmune DiseasesCrohn DiseasePsoriasisSpondylitis, AnkylosingArthritis, Psoriatic

Criteria

1 inclusion criteria required to participate
Currently pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California, San Diego

San Diego, United StatesOpen University of California, San Diego in Google Maps
SuspendedOne Study Center