Clinical trial NCT02775656: UCB Cimzia Pregnancy Follow-up Study
Official title: An Observational Follow-up Study of Women Who Become Pregnant While Participating in a Certolizumab Pegol (CZP) Clinical Study or Whose Pregnancies Have Otherwise Been Reported to UCB Due to Potential CZP Exposure During Pregnancy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis (RA)
Crohn's Disease (CD)
Psoriatic Arthritis (PsA)
Axial Spondyloarthritis and Ankylosing Spondylitis
Keywords: Cimzia®
CZP
Pregnancy Follow up study
Autoimmune diseases
Pregnancy outcomes
major congenital malformations
birth outcomes
malformation
birth defect
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Parexel
First posted: 2016-05-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of women who become pregnant while enrolled in a Certolizumab Pegol (CZP) study, or whose pregnancies otherwise are reported to UCB due to potential CZP exposure during pregnancy, and any resulting offspring. All pregnancies reported while the patient is enrolled in the CZP study are eligible regardless of treatment arm in the CZP study (eg, commercial or investigational CZP, placebo, or comparator treatment), pregnancy outcome (eg, live birth,spontaneous abortion, induced abortion, stillbirth) or any treatment decisions following discontinuation from the clinical study or report of the pregnancy.

Brief summary: The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnancy is identified while the patient is participating in an interventional or noninterventional Certolizumab Pegol (CZP) study conducted by UCB, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to UCB due to potential CZP exposure during pregnancy
* Sufficient information to classify the pregnancy as prospective or retrospective is available
* Full initial reporter (ie, woman or healthcare provider (HCP)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable HCP if initial contact is the woman
* Consent to participate is provided

Exclusion Criteria:

* Pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study

Primary outcomes:
measure: Percentage of newborns with major congenital malformations
timeFrame: At 20 weeks gestation or greater
measure: Percentage of pregnancy outcomes with major congenital malformations
timeFrame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary outcomes:
measure: Numbers of maternal pregnancy-related events
timeFrame: During pregnancy up to Week 40
measure: Percentage of Vaginal and C-section deliveries
timeFrame: At birth (Day 0)
measure: Gestational age at birth
timeFrame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
measure: Birth weight
timeFrame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
measure: Small for gestation age
timeFrame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
measure: Percentage of adverse events in infants
timeFrame: Within the first 18 months of life
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
timeFrame: 18 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
timeFrame: At birth (Day 0)
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
timeFrame: 4 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
timeFrame: 12 months
measure: Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
timeFrame: 18 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Up0019 001
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Cares
role: STUDY_DIRECTOR
References: