Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis

NCT00658827 | Completed

• 2 other identifiers: CR013141C0168T71
• Study Type: observational
• Target: 370
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease; Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Psoriasis; Pregnant women exposed to infliximab

Outcome Measures

Primary Outcomes (6)

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

  5 years

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

  Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.

  5 years

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

  5 years

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

  5 years

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

  Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.

  5 years

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

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (8)

Group 1a: Remicade Cohort

Female patients who were exposed to Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).

Other: No intervention

Group 1b: Remicade Cohort

Infants born to Group 1a patients.

Other: No intervention

Group 2a: Other Anti-TNF agents Cohort

Female patients who were exposed to anti-TNFs other than Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).

Other: No intervention

Group 2b: Other Anti-TNF agents Cohort

Infants born to Group 2a patients.

Other: No intervention

Group 3a: Non-biologic Systemic Therapy Control Cohort

Female patients who were exposed to systemic therapy other than biologic agents at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).

Other: No intervention

Group 3b: Non-biologic Systemic Therapy Control Cohort

Infants born to Group 3a patients.

Other: No intervention

Group 4a: Population Control Cohort

Female patients with no record of the diseases of interest and no exposure to biologic or non-biologic systemic therapy at any time during pregnancy (and up to 3 months prior to LMP, if the information is available).

Other: No intervention

Group 4b: Population Control Cohort

Infants born to Group 4a patients.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Group 1a: Remicade Cohort; Group 1b: Remicade Cohort; Group 2a: Other Anti-TNF agents Cohort; Group 2b: Other Anti-TNF agents Cohort; Group 3a: Non-biologic Systemic Therapy Control Cohort; Group 3b: Non-biologic Systemic Therapy Control Cohort; Group 4a: Population Control Cohort; Group 4b: Population Control Cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients of child bearing age with one of the diseases of interest and infants delivered by such patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Biotech, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Psoriasis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Janssen Biotech, Inc. Clinical Trial

  Janssen Biotech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: January 1, 2007
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01