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临床试验/NCT00658827
NCT00658827已完成不适用

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

Janssen Biotech, Inc.0 个研究点目标入组 370 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
370
主要终点
Number of normal live birth observed in pregnant women exposed and not exposed to infliximab

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 5 years

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

时间窗: 5 years

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

时间窗: 5 years

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 5 years

次要结局

  • Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

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