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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Parexel | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort | For a pregnancy to be enrolled in the prospective cohort, the pregnancy outcome cannot be known (ie, no prenatal diagnosis of a fetus with a congenital defect and the pregnancy is still ongoing at the time of consent). | ||
| Retrospective cohort | For a pregnancy to be enrolled in the retrospective cohort, the pregnancy outcome must already be known (ie, a congenital defect has already been identified at the time of consent into the pregnancy follow-up study, or the pregnancy has been completed at the time of consent). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of newborns with major congenital malformations | The prevalence of major congenital malformations (MCMs) reported will be calculated by dividing the number of offspring with MCMs by the total number of live births and fetal losses with an MCM for all enrolled pregnancies and then stratified by treatment during pregnancy. The prevalence of MCMs will be calculated as soon as there are at least 50 prospectively-enrolled patients with an available outcome. Stillbirths and induced abortions (at 20 weeks gestation or greater) with reported MCMs are included in the estimate of the MCM prevalence. | At 20 weeks gestation or greater |
| Percentage of pregnancy outcomes with major congenital malformations | The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure. | Estimated date of delivery (EDD) up to 6 weeks post-EDD |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of maternal pregnancy-related events | Descriptive statistics will be presented for the numbers of maternal pregnancy-related adverse events (AEs), adverse birth. Frequencies and proportions of adverse pregnancy will be presented using descriptive statistics. Analyses may include (but are not limited to) stratification by trimester of exposure, gestational age at time of consent, maternal age, and geographic region. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0019 001 | Wilmington | North Carolina | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003424 | Crohn Disease |
| D015535 | Arthritis, Psoriatic |
| D000089183 | Axial Spondyloarthritis |
| D013167 | Spondylitis, Ankylosing |
| D001327 | Autoimmune Diseases |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| During pregnancy up to Week 40 |
| Percentage of Vaginal and C-section deliveries | At birth (Day 0) |
| Gestational age at birth | Estimated date of delivery (EDD) up to 6 weeks post-EDD |
| Birth weight | Estimated date of delivery (EDD) up to 6 weeks post-EDD |
| Small for gestation age | Estimated date of delivery (EDD) up to 6 weeks post-EDD |
| Percentage of adverse events in infants | Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months) | Within the first 18 months of life |
| 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) | At birth (Day 0) |
| 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) | At birth (Day 0) |
| 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) | At birth (Day 0) |
| 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) | 4 months |
| 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) | 4 months |
| 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) | 4 months |
| 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) | 12 months |
| 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) | 12 months |
| 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) | 18 months |
| 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) | 18 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | At birth (Day 0) |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 4 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 12 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 18 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | At birth (Day 0) |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 4 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 12 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 18 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | At birth (Day 0) |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 4 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 12 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 18 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | At birth (Day 0) |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 4 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 12 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 18 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | At birth (Day 0) |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 4 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 12 months |
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills | Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'. | 18 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000844 | Ankylosis |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |