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

September 1, 2017 updated by: Janssen Biotech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients of child bearing age with one of the diseases of interest and infants delivered by such patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1a: Remicade Cohort
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).
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 1b: Remicade Cohort
Infants born to Group 1a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 2a: Other Anti-TNF agents Cohort
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).
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 2b: Other Anti-TNF agents Cohort
Infants born to Group 2a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 3a: Non-biologic Systemic Therapy Control Cohort
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).
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 3b: Non-biologic Systemic Therapy Control Cohort
Infants born to Group 3a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 4a: Population Control Cohort
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).
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 4b: Population Control Cohort
Infants born to Group 4a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Biotech, Inc.

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013141
  • C0168T71 (Other Identifier: Janssen Biotech, Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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