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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT00658827
First received: April 11, 2008
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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, Danish and Finnish Medical Birth Registers

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • Number of normal live birth observed in pregnant women exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.

  • Number of fetal death observed in pregnant women exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity.

  • Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 370
Study Start Date: October 2006
Estimated Study Completion Date: September 2014
Groups/Cohorts Assigned Interventions
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
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 1b: Remicade Cohort
Infants born to Group 1a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
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
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 2b: Other Anti-TNF agents Cohort
Infants born to Group 2a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
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
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 3b: Non-biologic Systemic Therapy Control Cohort
Infants born to Group 3a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
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
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
Group 4b: Population Control Cohort
Infants born to Group 4a patients.
Other: No intervention
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Detailed 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.

  Eligibility

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Janssen Biotech, Inc.
Merck Sharp & Dohme Corp.
Investigators
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.
  More Information

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT00658827     History of Changes
Other Study ID Numbers: CR013141, C0168T71
Study First Received: April 11, 2008
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Biotech, Inc.:
Inflammatory Bowel Disease
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Psoriasis
Pregnant women exposed to infliximab

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on July 31, 2014