Autoimmune diseases affect many women who are in their reproductive years, yet many of the medications used to treat autoimmune disease have not been well studied for use in pregnancy. The Autoimmune Diseases in Pregnancy Study is researching whether medications that are used to treat autoimmune diseases are safe to take during pregnancy. Specifically, we are looking at medications used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and multiple sclerosis. If you have one of these medical conditions and you are currently pregnant, you may qualify for this study.
- What type of study is this?
- What will I be asked to do and how much time will it take?
- What types of questions will I be asked?
- What treatments are you studying?
- How will my privacy be protected?
- What are the benefits of joining?
What type of study is this?
This is an observational study, meaning that we will simply follow-you throughout your pregnancy. You will NOT be asked to:
- Change anything about your prenatal care
- Change any medications that you are taking
- Undergo any invasive procedures
What will I be asked to do and how much time will it take?
You will be asked to:
- Participate in two to four phone calls (after the initial phone interview, these will only take 10 minutes of your time)
- Answer questions about your health history, your pregnancy and the birth of your child
- Provide us with copies of your medical records related to your pregnancy (see privacy and security)
What types of questions will I be asked?
You will be asked about:
- Exposures to medications, chemicals, illnesses and other environmental exposures during your pregnancy
- The dates when the exposures occurred as well as the dose and amount of exposure
What treatments are you studying?
We’re currently studying the following medications:
Actemra® (tocilizumab) is a prescription medication used for the treatment of rheumatoid arthritis and juvenile rheumatoid arthritis (JRA). Actemra® is given by intravenous infusion in a doctor’s office or clinic approximately once per month.
Aubagio® (teriflunomide) is a prescription medication used to treat relapsing forms of multiple sclerosis. Aubagio® is a pill taken by mouth, typically once a day.
Cimzia® (certolizumab pegol) is a prescription medication used to treat Crohn’s Disease, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Cimzia® is given as an injection under the skin one time every 2-4 week.
Entyvio® (vedolizumab) is a prescription medication used to treat moderate/severe Crohn’s Disease and ulcerative colitis. Entyvio® is given by intravenous infusion in a doctor’s office or clinic every 8 weeks (after an initial induction therapy with a shorter dosing frequency).
Humira® (adalimumab) is a prescription medication used to treat autoimmune conditions such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Humira® is given as an injection under the skin typically every 2 weeks.
Leflunomide, also known as Arava®, is a prescription medication approved for the treatment of rheumatoid arthritis. Leflunomide is a pill taken by mouth typically one time per day.
Orencia® (abatacept) is a prescription medication approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis (JIA). Orencia® can be given by intravenous infusion in a doctor’s office or clinic, or can be given as an injection under the skin.
Otezla® (apremilast) is a prescription medication approved for the treatment of moderate/severe plaque psoriasis and active psoriatic arthritis. Otezla® is a pill taken by mouth, typically twice a day.
Stelara® (ustekinumab) is a prescription medication used to treat moderate/severe plaque psoriasis, active psoriatic arthritis, and Crohn’s Disease. Stelara® is given as an injection under the skin one time every 12 weeks (after an initial shorter dosing frequency).
Xeljanz® (tofacitinib) is a prescription medication used to treat rheumatoid arthritis. Xeljanz® is a pill taken by mouth, typically twice a day.
How will my privacy be protected?
Information that we obtain from your medical record is vital to maintaining the high quality of our research. All of your personal health information will be kept confidential.
The MotherToBaby research team views privacy as one of our most important considerations when dealing with personal health information. We are required by law to comply with the strict rules and regulations set forth by state and federal agencies as well as the Institutional Review Board (IRB) at the University of California, San Diego, who oversees and monitors all research protocols. Once you agree to participate in a study, we will need to obtain your permission for the release of your medical records and will give you detailed information about who will have access to your health information and how the information will be used in ways that protect your privacy.
What are the benefits of joining?
- You will have peace of mind knowing that our information specialists are available to answer any questions that you may have about medications and other exposures before, during and after your pregnancy and while breastfeeding. We are eager to answer your questions, so call us toll-FREE at (877) 311-8972 to reach an information specialist.
- You may be eligible to receive a free expert medical evaluation and detailed examination of your baby by one of our pediatric specialists.
- You may have an exciting opportunity to learn about your baby’s developmental milestones by completing one or more specially designed questionnaires.
- You will be kept abreast of the results of the study and feel the pride of knowing that you made an invaluable contribution.