INFORMATION FOR HEALTH CARE PROVIDERS (US Only)
EXPECT is the Xolair® Pregnancy Registry: An Observational Study Of The Use and Safety Of Xolair® (Omalizumab) During Pregnancy
- What is Xolair?
- Primary Objective
- Eligibility Criteria
- What does the EXPECT Xolair Pregnancy Registry involve?
- How is data collected by the Registry then analyzed and reported?
- How can Healthcare Providers help?
- What is the patient compensation for enrollment in the study?
- How long will the study run?
- Why is the Registry important?
- Where can I get more information?
Xolair is indicated for adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.
To evaluate pregnancy outcomes in women exposed to Xolair within 8 weeks prior to conception or at any time during pregnancy.
Pregnant women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.
Patients do not need to be on Xolair currently in order to enroll.
What does the EXPECT Xolair Pregnancy Registry involve?
A woman participating in the study will be followed to the completion of her pregnancy. She will be asked to answer questions regarding her health and her infant’s health during a telephone interview at each trimester, at the time of delivery, and every 6 months until the infant is one year old. If the woman continues Xolair treatment while breastfeeding, she will be asked to participate in one additional phone interview when the infant is 18 months old. No clinic visits are required.
The registry representative will obtain the woman’s verbal consent to participate in the study and then will assess her eligibility. If she qualifies and agrees to participate, she also will be asked to provide written Informed Consent and HIPAA forms. After receipt of these forms, all relevant healthcare providers (obstetrician, asthma specialist, pediatrician or other physician) will be contacted by a Registry Center representative via telephone.
How is data collected by the Registry then analyzed and reported?
The data is collected through the Xolair Pregnancy Registry Center by telephone and managed by a Contract Research Organization called PPD. No study site visits are required. A Scientific Advisory Board was formed to oversee the registry data, analysis, and presentation of results. The Board is comprised of specialists in neonatology, teratology, pediatrics, allergy/asthma, obstetrics, and gynecology.
How can Healthcare Providers help?
If you have patients taking Xolair who meet initial eligibility requirements, please have them call the toll free number at 1-(866)-4XOLAIR (496-5247) Option 3. Here they will be able to enroll in the Xolair Pregnancy Registry. Patients must enroll themselves. However, healthcare providers are encouraged to direct eligible patients to the registry and to call the toll-free phone number if they have any questions.
What is the patient compensation for enrollment in the study?
Patients enrolled in the registry will be compensated $25 for each telephone survey they complete.
The registry will be active for a minimum of five years or until 250 women are screened and enrolled.
Why is the Registry important?
There are no adequate and well-controlled studies of Xolair in pregnant women. Xolair should be used during pregnancy only if clearly needed. While Xolair presence in human milk has not been studied, IgG is excreted in human milk and, therefore, it is expected that Xolair will be present in human milk. The potential for Xolair absorption or harm to the infant are unknown; caution should be exercised when administering Xolair to a nursing woman.
Data collected in the Xolair Pregnancy Registry Center may be used to assist physicians and patients in weighing the risks of Xolair exposure in pregnancy. The clinical study is an essential component of ongoing efforts to understand the effects of Xolair during pregnancy and nursing.
Participation in the Registry will provide important information to physicians and patients regarding the use of Xolair during pregnancy. This Registry is the primary source for collecting and evaluating exposure to Xolair during pregnancy. The success of the Registry relies on participation of patients and healthcare providers.
Where can I get more information?
For additional information, please call the Xolair Pregnancy Registry Center toll-free at: 1-(866)-4XOLAIR (496-5247), Option 3.
