NCT00658827

Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis

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, Danish and Finnish Medical Birth Registers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 370 (actual)
• Sponsor: Janssen Biotech, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients; and information pertaining to health status, during the first year following delivery, of infants born to women following prenatal exposure to infliximab and their unexposed counterparts.

Detailed description

This registry will analyze birth outcomes data from Medical Birth Registers 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 \[CD\] and Ulcerative Colitis \[UC\]), Rheumatoid Arthritis \[RA\], Psoriatic Arthritis \[PsA\], Ankylosing Spondylitis \[AS\], and Psoriasis (Pso) 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 Swedish national health registries (a. Swedish Medical Birth Register \[SMBR\] b. Swedish Prescribed Drug Register c. Swedish Patient Register \[PAR\]), Danish national health registries (a. Danish Medical Birth Register \[DMBR\] b. Danish Register of Medicinal Product Statistics c. Danish National Patient Registry), and Finnish national health registries (a. Finnish Medical Birth Register \[FMBR\] b. Finnish Register on Prescribed Medicine c. Finnish National Care Register for Health Care Institutions \[HILMO\] d. Finnish Register on Congenital Malformations) during the 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. No study medications will be administered in this registry. Treatments are as prescribed by the physician on the basis of usual clinical practice.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
OTHER	No intervention	This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Timeline

• Start date: 2007-01-01
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2008-04-15
• Last updated: 2025-02-03