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

Inflammatory Bowel Disease Clinical Trial

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, Danish and Finnish Medical Birth Registers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658827
• Other study ID #: CR013141
• Secondary ID: C0168T71
• Status: Completed
• Phase: N/A
• First received: April 11, 2008
• Last updated: September 1, 2017
• Start date: January 1, 2007
• Est. completion date: September 30, 2016

Study information

• Verified date: September 2017
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Study patients must meet the following criteria: Women of childbearing age with birth outcomes recorded in either the Swedish Medical Birth Register (SMBR), Finnish Medical Birth Register (FMBR) or in the Danish Medical Birth Register (DMBR) who have confirmed diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or psoriasis and documented exposure to infliximab during pregnancy and infants born to these women

• Control patients must meet the following criteria: Women of childbearing age with birth outcomes recorded in either the SMBR, FMBR or DMBR who have confirmed diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or psoriasis, and no exposure to biologics during pregnancy and infants born to these women

Exclusion Criteria:

• Information for women who do not have a documented history of the diseases of interest but whose birth outcomes are included in the SMBR, FMBR or DMBR during the study period and the infants of these women

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Psoriasis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of normal live birth observed in pregnant women exposed and not exposed to infliximab		5 years
Primary	Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab	Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.	5 years
Primary	Number of fetal death observed in pregnant women exposed and not exposed to infliximab		5 years
Primary	Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab		5 years
Primary	Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab	Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.	5 years
Primary	Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab		5 years
Secondary	Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants		5 years