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NCT04846959 · ClinicalTrials.gov registry record
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
A clinical trial of Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment, sponsored by AbbVie.
- Recruiting
- Registry status
- 818
- Enrollment target
- 2
- Study locations
NCT04846959: Recruiting study of Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment, sponsored by AbbVie.
NCT04846959 is a study of Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment that is actively recruiting participants, run by AbbVie. The registered enrollment target is 818 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04846959, a study of Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- 818 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Risankizumab
- DRUG Comparator
Study Locations (2)
North Carolina
- Evidera, a PPD Business Unit /ID# 238688 - Morrisville
- PPD Development, LP /ID# 232134 - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 818 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2032-06 |
What NCT04846959 shows while recruiting
NCT04846959 is an observational study that tracks outcomes without assigning an intervention. The registered 818 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment appearing as the primary indexed condition, and to 2 interventions - of which Risankizumab is the first listed.
NCT04846959 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04846959 about?
NCT04846959 is a clinical study titled "Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications". 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 ...
What is the current status of trial NCT04846959?
This trial is currently recruiting. The enrollment target is 818 participants. The study started on 2021-07-30. Estimated completion is 2032-06.
What conditions does trial NCT04846959 study?
This clinical trial studies the following conditions: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment.
What interventions are being tested in trial NCT04846959?
The interventions under investigation include: Risankizumab (DRUG), Comparator (DRUG).
Who is sponsoring clinical trial NCT04846959?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04846959 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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