Analysis of Birth Outcomes of Swedish and Danish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
| 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:
- 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
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