What this study is
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.
What's being tested
- Risankizumab
Intervention · DRUG
Subcutaneous Injection
- Comparator
Intervention · DRUG
Subcutaneous or Intravenous Injection
Study details
- Official title
- Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring
- Sponsor
- AbbVie
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
- Enrolling
- 818 people
- Starts
- 2021-07-30
- Est. completion
- 2032-06
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openEvidera, a PPD Business Unit /ID# 238688
Morrisville, North Carolina, United States
RecruitingPPD Development, LP /ID# 232134
Wilmington, North Carolina, United States
Completed
Study team
Sponsor
AbbVie
Study ID P20-036
Study director
ABBVIE INC.
AbbVie
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.