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Analysis of Birth Outcomes of Swedish and Danish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis.
This study is enrolling participants by invitation only.
Study NCT00658827   Information provided by Centocor, Inc.
First Received: April 11, 2008   Last Updated: February 27, 2009   History of Changes

April 11, 2008
February 27, 2009
 
 
 
 
Complete list of historical versions of study NCT00658827 on ClinicalTrials.gov Archive Site
 
 
 
Analysis of Birth Outcomes of Swedish and Danish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis.
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 and Danish Medical Birth Registers.

This will be a 5-year observational study gathering birth outcome data for infants born to mothers exposed to infliximab and follow-up data on the health status of infants at approximately one year of age.

This registry will analyze birth outcomes data from the Swedish Medical Birth Register (SMBR) and the Danish Medical Birth Register (DMBR) 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 and Ulcerative Colitis), Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, 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 SMBR, DMBR, the Danish Register of Medicinal Product Statistics, and the Danish National Patient Registry during the anticipated 5-year 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 from the Swedish Prescription Drug Register, the Swedish Hospital Discharge Register, the Danish Register of Medicinal Product Statistics, and the National Patient Registry.

No study agents will be administered in this registry. Treatments are as prescribed by the physician on the basis of usual clinical practice.

Phase IV
Observational
Other
  • Inflammatory Bowel Disease
  • Psoriasis
  • Ankylosing Spondylitis
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
370
 
 

Inclusion Criteria:

  • Study patients must meet the following criteria: Women of childbearing age with birth outcomes recorded in either the SMBR or in the DMBR
  • Confirmed diagnosis of CD, UC, RA, PsA, AS, PsO
  • Documented exposure to infliximab during pregnancy
  • Infants born to these women
  • Control patients must meet the following criteria
  • Women of childbearing age with birth outcomes recorded in either the SMBR or in the DMBR
  • Confirmed diagnosis of CD, UC, RA, PsA, AS, PsO
  • No exposure to infliximab during pregnancy
  • 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 or in the DMBR during the study period and the infants of these women will be excluded
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00658827
 
CR013141
Centocor, Inc.
Schering-Plough
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP