OTIS Autoimmune Diseases in Pregnancy Project
You can help other pregnant women - please volunteer today!
Research into the effects of medications in pregnancy needs volunteers like you! If you are pregnant, you may be able to help. Please call or email to learn more about these research studies.
Are you pregnant? | |
You may be eligible for the OTIS Autoimmune Diseases in Pregnancy Project
| If you are pregnant and have Autoimmune diseases affect many women who are in their reproductive years. Many of the medications used to treat autoimmune diseases have not been well studied for use in pregnancy. | |
| About the research study... The OTIS Autoimmune Disease in Pregnancy Project is a North American effort to evaluate safety of medications used for the treatment of autoimmune diseases in pregnancy. If you have an autoimmune disease and are pregnant you may qualify for this research study. Eligible participants receive follow-up phone calls during pregnancy, and your child will receive a pediatric exam, performed by one of our participating physicians at no cost to you. | |
Learn More About Medications Used to Treat AI Diseases and Pregnancy
Please download these files for more information:
Chambers CD, Johnson DL, Robinson LK, Braddock SR, Xu R, Lopez-Jimenez J, Mirrasoul N, Salas E, Luo YJ, Jin S, Jones KL. Birth outcomes in women who have taken leflunomide during pregnancy. Abstract: Birth outcomes in pregnant women taking leflunomide. Arthritis Rheum. 2010 May;62(5):1494-503. [ PDF Download, 36KB]
Poster presentation: Pregnancy Outcomes in Women Exposed to Adalimumab: An Update on the Autoimmune Diseases in Pregnancy Project. Presented at the American College of Gastroenterology meeting in San Diego, CA on October 25, 2009. [PDF Download, 52KB]
Poster presentation: Pregnancy Outcome in Women Exposed to Etanercept: The OTIS Autoimmune Diseases in Pregnancy Project. Presented at the American College of Rheumatology (ACR) in San Francisco, CA October 2008. [PDF Download, 52KB]
This recent publication reviews the pregnancy safety information for RA Medications and discusses this and other research studies:
Chambers CD, Tutuncu ZN, Johnson D and Jones KL. 2006. Review: Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data. Arthritis Research & Therapy 8:225. [PDF Download, 82 KB]
Current Study Participants: Download Forms Here
Change of Address Form (English) [DOC Download, 32 KB]
Change of Address Form (Spanish) [DOC Download, 32 KB]
Physician Info Form (English) [DOC Download, 68 KB]
Physician Info Form (Spanish) [DOC Download, 36 KB]
Diary (English) [DOC Download, 56 KB]
Diary (Spanish) [DOC Download, 56 KB]
Healthcare Professionals:
Please use this form to refer your patients to our study:Referral Form [Fax_referral_form_AI.doc, 366KB] Referral Form [Fax_referral_form_AI.pdf, 210KB] | |
Research Study Sponsors:
| Abbott Laboratories | Amgen | Apotex | Barr | Bristol-Myers Squibb |
| Par Pharmaceutical | Sandoz | Sanofi-aventis | Teva |
| All information collected will remain strictly confidential. Identity of the women and their children will not be used in any report or publication and all files are kept in a locked cabinet. The coordinating center for the research study is located at the University of California, San Diego Medical Center in the Department of Pediatrics. The medical director is Dr. Kenneth Lyons Jones, a pediatrician and specialist in birth defects. *OTIS is a national organization committed to research and the education of pregnant women and health care professionals about exposures during pregnancy. |