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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00658827

C0168T71 (Other Identifier)

CR013141

Details and patient eligibility

About

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.

Full description

This registry will analyze birth outcomes data from Medical Birth Registers 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 [CD] and Ulcerative Colitis [UC]), Rheumatoid Arthritis [RA], Psoriatic Arthritis [PsA], Ankylosing Spondylitis [AS], and Psoriasis (Pso) 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 Swedish national health registries (a. Swedish Medical Birth Register [SMBR] b. Swedish Prescribed Drug Register c. Swedish Patient Register [PAR]), Danish national health registries (a. Danish Medical Birth Register [DMBR] b. Danish Register of Medicinal Product Statistics c. Danish National Patient Registry), and Finnish national health registries (a. Finnish Medical Birth Register [FMBR] b. Finnish Register on Prescribed Medicine c. Finnish National Care Register for Health Care Institutions [HILMO] d. Finnish Register on Congenital Malformations) during the 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. No study medications will be administered in this registry. Treatments are as prescribed by the physician on the basis of usual clinical practice.

Enrollment: 370 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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, FMBR or DMBR during the study period and the infants of these women

Trial design

370 participants in 8 patient groups

Group 1a: Remicade Cohort

Description:

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).

Treatment:

Other: No intervention

Group 1b: Remicade Cohort

Description:

Infants born to Group 1a patients.

Treatment:

Other: No intervention

Group 2a: Other Anti-TNF agents Cohort

Description:

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).

Treatment:

Other: No intervention

Group 2b: Other Anti-TNF agents Cohort

Description:

Infants born to Group 2a patients.

Treatment:

Other: No intervention

Group 3a: Non-biologic Systemic Therapy Control Cohort

Description:

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).

Treatment:

Other: No intervention

Group 3b: Non-biologic Systemic Therapy Control Cohort

Description:

Infants born to Group 3a patients.

Treatment:

Other: No intervention

Group 4a: Population Control Cohort

Description:

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).

Treatment:

Other: No intervention

Group 4b: Population Control Cohort

Description:

Infants born to Group 4a patients.

Treatment:

Other: No intervention