Overview

This trial is active, not recruiting.

Condition inflammatory bowel disease
Treatment no intervention
Phase phase 4
Sponsor Janssen Biotech, Inc.
Collaborator Merck Sharp & Dohme Corp.
Start date January 2007
End date December 2017
Trial size 370 participants
Trial identifier NCT00658827, C0168T71, CR013141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Female patients who were exposed to Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Infants born to Group 1a patients.
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Female patients who were exposed to anti-TNFs other than Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Infants born to Group 2a patients.
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Female patients who were exposed to systemic therapy other than biologic agents at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Infants born to Group 3a patients.
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Female patients with no record of the diseases of interest and no exposure to biologic or non-biologic systemic therapy at any time during pregnancy (and up to 3 months prior to LMP, if the information is available).
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Infants born to Group 4a patients.
no intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Primary Outcomes

Measure
Number of normal live birth observed in pregnant women exposed and not exposed to infliximab
time frame: 5 years
Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab
time frame: 5 years
Number of fetal death observed in pregnant women exposed and not exposed to infliximab
time frame: 5 years
Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
time frame: 5 years
Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
time frame: 5 years
Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
time frame: 5 years

Secondary Outcomes

Measure
Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants
time frame: 5 years

Eligibility Criteria

Female participants of any age.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Janssen Biotech, Inc..