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NOW ENROLLING: OPZELURA® (RUXOLITINIB) CREAM 1.5% PREGNANCY REGISTRY IN WOMEN WITH ECZEMA (ATOPIC DERMATITIS)

The OPZELURA Pregnancy Registry is looking for participants who are between 15 and 50 years of age with mild to moderate eczema (atopic dermatitis) and are pregnant or have been pregnant in the last 12 months. Find out if you pre-qualify.

Newborn and Mother

About the OPZELURA Pregnancy Registry

This is a Pregnancy Registry of women (15-50 years) who applied OPZELURA to treat their eczema (atopic dermatitis) during their pregnancy. Pregnant women with eczema (atopic dermatitis) not exposed to OPZELURA may also be enrolled. The Registry will compare the outcomes of participants who used OPZELURA to treat their eczema (atopic dermatitis) with participants who did not use OPZELURA to treat their eczema (atopic dermatitis).

WHO IS ELIGIBLE TO JOIN?

You may qualify for the OPZELURA Pregnancy Registry if you:

  • woman

    Were assigned female at birth

  • Ages

    Are between the ages of 15 and 50 years old

  • Lightbulb

    Were diagnosed by your doctor with mild or moderate eczema (atopic dermatitis)

  • Pregnant

    Are pregnant now or have been pregnant in the last 12 months

This is not a complete list of Registry requirements. The Registry staff will review the full requirements for this Registry with you.

WHAT CAN I EXPECT IF I DECIDE TO PARTICIPATE?

The Registry will follow you during your pregnancy and up to 12 months after delivery of your baby. During this time, certain data will be collected about your eczema (atopic dermatitis) and pregnancy as well as your baby up to 1 year of age.

ENROLLMENT

If you agree to the Registry, you will be asked about your:
  • General medical and family history
  • Current or past pregnancy
  • Medications used to treat eczema (atopic dermatitis)

    • DURING THE REGISTRY

    The following information will be collected during your pregnancy and one year after your baby is born:

  • Pregnancy status
  • Delivery status
  • Certain pregnancy or delivery problems
  • Infant health
  • Medications used for eczema (atopic dermatitis)

    • AFTER PREGNANCY

    The Registry will collect information regarding your baby's health in their first year of life.

    The Registry will collect information regarding your baby's health in their first year of life.

    WHAT CAN I EXPECT IF I DECIDE TO PARTICIPATE?

    What is a Registry?

    A Pregnancy Registry is a study that collects health information from women who use prescription medicines while they are pregnant. Information is also collected on the newborn baby. The OPZELURA® (ruxolitinib) Cream 1.5% Pregnancy Registry is an observational research study that monitors the pregnancy status and outcomes in participants with mild to moderate eczema (atopic dermatitis) that have been treated with OPZELURA at anytime during pregnancy (24 days prior to conception through the end of the pregnancy) or up to 12 months after pregnancy outcome. Pregnant women with eczema (atopic dermatitis) not treated with OPZELURA may also be enrolled. The Registry is being conducted in the United States and is sponsored by Incyte. The Registry will help us learn more about the safety of OPZELURA use and other medications for the treatment of mild to moderate eczema (atopic dermatitis) during pregnancy by evaluating pregnancy outcomes and other health events. Pregnant women with eczema (atopic dermatitis) who were exposed to OPZELURA or other treatment are encouraged to enroll in the Registry as early in pregnancy as possible, preferably before information is known about the health of the baby from prenatal tests like ultrasounds. Eligible pregnant women may enroll in this study at any trimester of pregnancy including up to 12 months after pregnancy outcome.

    What will happen if I join this Registry?

    With your permission, a Registry Associate will determine if you are eligible to enroll by asking you a few questions in order to complete an eligibility screener form. Before you can join, the Registry staff will tell you more about the purpose of the Registry. You will also read and sign an Informed Consent Form (ICF). This document will tell you everything that will happen in the Registry. You can ask the Registry staff as many questions as you want before signing this form. This Registry will require you to give us some basic information about you and your eczema (atopic dermatitis) and your permission to contact your doctor. The Registry staff will then contact your doctor to collect pregnancy history, test results related to your pregnancy, and information about the time during your pregnancy you have been exposed to OPZELURA, if applicable. You will not have to make any extra office visits, take any extra tests, or take any additional medications. You will receive compensation for your time and effort for participation in this Registry.

    How will my personal data be used and protected?

    The Informed Consent Form will explain how the Registry staff will collect and use your personal data. Throughout the Registry your file will be kept confidential. Your personal identifying information will not be entered in the study database. Information about your pregnancy, but not your identity, may be reviewed by a Scientific Advisory Committee. If necessary, your Registry records, such as medical releases and/or case information may be reviewed by a Birth Defect Evaluator who works with the Registry. A report on the results of all pregnancies in the Registry, without any identifying information, will be submitted to the Food and Drug Administration (FDA) and other regulatory agencies and will be available to health care providers who participated in the Registry. Results of the Registry findings may be published, but we will never make your name, your baby’s name, or other identifying information available.
  • Talk to the Registry staff - they can explain the rules that are in place to help keep your Registry information private and secure

    • What are some of the risks and benefits of joining this Registry?

    There are risks and benefits to joining any Registry. The Registry staff will explain the possible risks and benefits of being in this Registry. Your participation is strictly voluntary. The Registry uses a series of questionnaires to gather information and does not involve any medical procedures. For these reasons, the only risks or discomforts that are expected associated with participating in this Registry are related to the possible loss of confidentiality and/or the emotional discomfort answering some of the questions. There are no direct benefits for your participation in this Registry. You will receive compensation for your time and effort for participation in this study in the form of a gift card. There may be benefits to other participants like you in the future. The results of this study may increase medical knowledge about the safety of using OPZELURA.

    Why take part in the Registry?

    Information learned from this Registry may help other people in the future. The results of this Registry may increase medical knowledge about the safety of OPZELURA during pregnancy.

    Can I leave the Registry after I start?

    Yes, you may leave the Registry at any time, for any reason. Taking part in any Registry is up to you. You may decide not to participate, or you may leave the Registry at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled. Your medical care will not be affected by choosing not to participate in the Registry. Your participation in this Registry may be stopped without your consent at any time and for any reason by your doctor, the sponsor, the FDA and other regulatory authorities.