Crohn'sRecruiting
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Observational · No treatment assigned · 2 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Women only
Some of the main requirements, copied from the record:
- Risankizumab-Exposed Cohort
- US resident.
- Current pregnancy.
Plus 7 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 818 participants are expected to take part.
- Start date: 2021-07-30.
- Main results expected around 2032-06 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in United States.
Main thing being measured
- Number of Participants with Major Congenital Malformation (MCM) (Up to 9 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment |
| Lead sponsor | AbbVie |
| Collaborators | PPD Development, LP |
| Enrollment | 818 (estimated) |
| Start date | 2021-07-30 |
| Primary completion (est.) | 2032-06 |
| First posted | 2021-04-15 |
| Last updated | 2025-07-17 |
| Official title | Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring |
| ClinicalTrials.gov ID | NCT04846959 |
Interventions
- Risankizumab (Drug)
Subcutaneous Injection - Comparator (Drug)
Subcutaneous or Intravenous Injection
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Evidera, a PPD Business Unit /ID# 238688 | Morrisville, North Carolina | United States | Recruiting |
| PPD Development, LP /ID# 232134 | Wilmington, North Carolina | United States | Completed |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.