Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

Conditions

• Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Subcutaneous Injection
• Comparator — DRUG
  Subcutaneous or Intravenous Injection

Study Details

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.

Key Dates

Start date

Jul 30, 2021

Status verified

Jul 2025

Primary completion

Jun 30, 2032

Completion

Jun 30, 2032

Study Design

Enrollment

818 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Number of Participants with Major Congenital Malformation (MCM) [ Time Frame: Up to 9 months ]

Central Contacts

• PPD Inc
  1-877-302-2161
  [email protected]

Locations (2)

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