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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.
Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States.
Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery
There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women Exposed to Risankizumab | Pregnant women of any age in the United States (US) who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and exposed to risankizumab at any time during pregnancy. |
| |
| Pregnant Women Not Exposed to Risankizumab | Pregnant women of any age in the US who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and not exposed to risankizumab, but who are exposed to other medications in the same class or line of therapy as risankizumab at any time during pregnancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Major Congenital Malformation (MCM) | MCM is an abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Minor Congenital Malformation | Minor Congenital Malformation is an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual. | Up to approximately 2 years (1 year post delivery) |
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Inclusion Criteria:
Risankizumab-Exposed Cohort
Diseased Comparison Cohort
Exclusion Criteria:
Risankizumab-Exposed Cohort
Diseased Comparison Cohort
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The study population will comprise 2 cohorts of pregnant women.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PPD Inc | Contact | 1-877-302-2161 | glowpregnancyregistry@ppd.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera, a PPD Business Unit /ID# 238688 | Recruiting | Morrisville | North Carolina | 27560-7200 | United States | |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Comparator | Drug | Subcutaneous or Intravenous Injection |
|
| Number of Participants with Stillbirth | Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at 20 gestational weeks or greater (>=20 gestational weeks), or, if gestational age is unknown, a fetus weighing 350 g or more (>=350 g). | Up to 9 months |
| Number of Participants with Spontaneous Abortion (SAB) | Spontaneous abortion is defined as an involuntary fetal loss or expulsion of products of conception occurring at less than 20 gestational weeks. | Up to 9 months |
| Number of Participants with Elective Termination of Pregnancy | Elective termination of pregnancy is defined as an voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively. | Up to 9 months |
| Number of Participants with Preterm Birth | Preterm birth is defined as live birth occurring at less than 37 gestational weeks. | Up to 9 months |
| Number of Participants who are Small for Gestational Age (SGA) | SGA is defined as Birth weight less than the 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants. | Up to 9 months |
| Number of Participants with Neonatal Death | Neonatal death is defined as death of a live-born infant within 28 days of life. | Up to approximately 10 months (one month post delivery) |
| Number of Participants with Serious Infection in the First 6 Months of Life | Serious infection is defined as an infection that occurs within an infant's first 6 months of life and results in significant disability, incapacity, or death, is life-threatening, requires inpatient or prolonged hospitalization, or is considered medically important. | Up to approximately 2 years (1 year post delivery) |
| Number of Participants with Postnatal Growth Deficiency | Postnatal growth deficiency is defined as postnatal infant weight less than the 10th percentile for sex and chronological age using standard growth charts. | Up to approximately 2 years (1 year post-delivery) |
| Number of Participants with Infant Developmental Delay | Infant developmental delay is defined as failure to achieve the developmental milestones for chronological age, as defined by the Center for Disease Control and Prevention (CDC) . | Up to approximately 2 years (1 year post delivery) |
| PPD Development, LP /ID# 232134 |
| Completed |
| Wilmington |
| North Carolina |
| 28401-3331 |
| United States |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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