Trial record 15 of 3270 for:    "Arthritis"

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.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00658827
First received: April 11, 2008
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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.


Condition Phase
Inflammatory Bowel Disease
Psoriasis
Ankylosing Spondylitis
Rheumatoid Arthritis
Psoriatic Arthritis
Phase 4

Study Type: Observational
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 and Danish Medical Birth Registers.

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Estimated Enrollment: 370
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658827

Sponsors and Collaborators
Centocor, Inc.
Schering-Plough
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00658827     History of Changes
Other Study ID Numbers: CR013141
Study First Received: April 11, 2008
Last Updated: February 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
pregnant women exposed to infliximab
AS
RA
IBD
CD
PsO
health status of infants exposed to infliximab
PsA
UC

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Intestinal Diseases
Psoriasis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013