Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Psoriasis
Pregnant women exposed to infliximab
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-04-15
Enrollment: 370
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of normal live birth observed in pregnant women exposed and not exposed to infliximab
timeFrame: 5 years
measure: Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab
timeFrame: 5 years
measure: Number of fetal death observed in pregnant women exposed and not exposed to infliximab
timeFrame: 5 years
measure: Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
timeFrame: 5 years
measure: Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
timeFrame: 5 years
measure: Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
timeFrame: 5 years
Secondary outcomes:
measure: Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Biotech, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: