Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risankizumab, Comparator.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring
Overview
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.
Interventions
- Drug Risankizumab
Subcutaneous Injection - Drug Comparator
Subcutaneous or Intravenous Injection
Primary outcome measures
- Number of Participants with Major Congenital Malformation (MCM) [Time frame: Up to 9 months]
Secondary outcome measures (10)
- Number of Participants with Minor Congenital Malformation [Time frame: Up to approximately 2 years (1 year post delivery)]
- Number of Participants with Stillbirth [Time frame: Up to 9 months]
- Number of Participants with Spontaneous Abortion (SAB) [Time frame: Up to 9 months]
- Number of Participants with Elective Termination of Pregnancy [Time frame: Up to 9 months]
- Number of Participants with Preterm Birth [Time frame: Up to 9 months]
- Number of Participants who are Small for Gestational Age (SGA) [Time frame: Up to 9 months]
- Number of Participants with Neonatal Death [Time frame: Up to approximately 10 months (one month post delivery)]
- Number of Participants with Serious Infection in the First 6 Months of Life [Time frame: Up to approximately 2 years (1 year post delivery)]
- Number of Participants with Postnatal Growth Deficiency [Time frame: Up to approximately 2 years (1 year post-delivery)]
- Number of Participants with Infant Developmental Delay [Time frame: Up to approximately 2 years (1 year post delivery)]
Eligibility criteria
Inclusion criteria
Risankizumab-Exposed Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
Diseased Comparison Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
Exclusion criteria
Risankizumab-Exposed Cohort
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
- Occurrence of pregnancy outcome prior to enrollment in the registry
Diseased Comparison Cohort
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
- Occurrence of pregnancy outcome prior to enrollment in the registry
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Evidera, a PPD Business Unit /ID# 238688 — Morrisville
- PPD Development, LP /ID# 232134 — Wilmington
Identifiers
NCT: NCT04846959 · P20-036