Inflammatory Bowel DiseaseNCT00658827
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
An observational study of Inflammatory Bowel Disease, run by Janssen Biotech, Inc..
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female patients of child bearing age with one of the diseases of interest and infants delivered by such patients.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- No intervention
- Keywords
- Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis, Pregnant women exposed to infliximab
- Medical subject headings
- Inflammatory Bowel Diseases, Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: No intervention | |
| Group 1b: Remicade Cohort | Infants born to Group 1a patients. Receives: 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). Receives: Other: No intervention | |
| Group 2b: Other Anti-TNF agents Cohort | Infants born to Group 2a patients. Receives: 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). Receives: Other: No intervention | |
| Group 3b: Non-biologic Systemic Therapy Control Cohort | Infants born to Group 3a patients. Receives: 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). Receives: Other: No intervention | |
| Group 4b: Population Control Cohort | Infants born to Group 4a patients. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of normal live birth observed in pregnant women exposed and not exposed to infliximab
Measured: 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.
Measured: 5 years
Number of fetal death observed in pregnant women exposed and not exposed to infliximab
Measured: 5 years
Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
Measured: 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.
Measured: 5 years
Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
Measured: 5 years
Secondary outcomes (1)
Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study start1 Jan 2007
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Janssen Biotech, Inc. Clinical Trial, Study director, Janssen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658827
- Sponsor's protocol ID
- CR013141
- Other IDs
- C0168T71
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2008
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00658827
- Acronym / sponsor ID
- CR013141
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis, Pregnant women exposed to infliximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1a: Remicade Cohort | – | Other: No interventionFemale patients who were exposed to Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). |
| Group 1b: Remicade Cohort | – | Other: No interventionInfants born to Group 1a patients. |
| Group 2a: Other Anti-TNF agents Cohort | – | Other: No interventionFemale 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). |
| Group 2b: Other Anti-TNF agents Cohort | – | Other: No interventionInfants born to Group 2a patients. |
| Group 3a: Non-biologic Systemic Therapy Control Cohort | – | Other: No interventionFemale 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). |
| Group 3b: Non-biologic Systemic Therapy Control Cohort | – | Other: No interventionInfants born to Group 3a patients. |
| Group 4a: Population Control Cohort | – | Other: No interventionFemale 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). |
| Group 4b: Population Control Cohort | – | Other: No interventionInfants born to Group 4a patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients of child bearing age with one of the diseases of interest and infants delivered by such patients.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed. | Other | 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 |
Primary outcome
Number of normal live birth observed in pregnant women exposed and not exposed to infliximab
Time frame: 5 years
Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab
Time frame: 5 years
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
Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
Time frame: 5 years
Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab
Time frame: 5 years
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
1 secondary outcome
Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Biotech, Inc. Clinical Trial study director
Janssen Biotech, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Janssen Biotech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of normal live birth observed in pregnant women exposed and not exposed to infliximab (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.