CompletedNot Applicable

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

370 participantsStarted 2007-01-01

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of normal live birth observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of fetal death observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years

Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years

Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years

Trial details

NCT IDNCT00658827

SponsorJanssen Biotech, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-09-30

View on ClinicalTrials.gov More Inflammatory Bowel Disease trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of normal live birth observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of fetal death observed in pregnant women exposed and not exposed to infliximab

Timeframe: 5 years

Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years

Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years

Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab

Timeframe: 5 years