Analysis of Birth Outcomes of Swedish and Danish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis.
This will be a 5-year observational study gathering birth outcome data for infants born to mothers exposed to infliximab and follow-up data on the health status of infants at approximately one year of age.
Inflammatory Bowel Disease
|Official Title:||Exposure to Remicade (Infliximab) During Pregnancy in Patients With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Psoriasis: a Review and Analysis of Birth Outcomes From the Swedish and Danish Medical Birth Registers.|
This registry will analyze birth outcomes data from the Swedish Medical Birth Register (SMBR) and the Danish Medical Birth Register (DMBR) on approximately 370 women who have become pregnant and have been exposed to infliximab with the diseases of interest: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, as well as all women with the same diseases who have not been exposed to infliximab. Demographics and information related to the diseases of interest, past medical history, infliximab exposure during pregnancy (and up to 3 months prior to conception), use of other medications, and pregnancy outcomes information and infant birth information will be collected from the SMBR, DMBR, the Danish Register of Medicinal Product Statistics, and the Danish National Patient Registry during the anticipated 5-year study period. The health status of infants born to these women will be followed for 1 year after birth. During the 1-year follow-up period, information related to hospitalizations and antibiotic use will be obtained from the Swedish Prescription Drug Register, the Swedish Hospital Discharge Register, the Danish Register of Medicinal Product Statistics, and the National Patient Registry.
No study agents will be administered in this registry. Treatments are as prescribed by the physician on the basis of usual clinical practice.