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| Sponsor: | Centocor, Inc. |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00658827 |
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 IV |
| 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. |
| Estimated Enrollment: | 370 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CR013141 |
| Study First Received: | April 11, 2008 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00658827 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
pregnant women exposed to infliximab AS RA IBD CD |
PsO health status of infants exposed to infliximab PsA UC |
|
Anti-Inflammatory Agents Infliximab Gastrointestinal Diseases Arthritis, Rheumatoid Inflammatory Bowel Diseases Infection Bone Diseases Musculoskeletal Diseases Psoriasis Therapeutic Uses Arthritis Connective Tissue Diseases Spondylitis, Ankylosing Dermatologic Agents Spondylarthritis |
Spondylitis Ankylosis Spondylarthropathies Spinal Diseases Autoimmune Diseases Skin Diseases Immune System Diseases Arthritis, Psoriatic Joint Diseases Gastrointestinal Agents Rheumatic Diseases Intestinal Diseases Pharmacologic Actions Bone Diseases, Infectious Digestive System Diseases |