Inflammatory Bowel DiseasesEVASIONNCT03134508
Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- treated by antiTNFα and not treated by antiTNFα
- How many people
- 8,726 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Apr 2017
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All pregnant women with a diagnosis of IBD
Who may be able to join
- pregnancy between 01/01/2011 and 31/12/2014
- Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)
Who cannot join
- Non IBD indication of antiTNFα treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- treated by antiTNFα, not treated by antiTNFα
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated by antiTNFαOther
pregnant IBD women treated by antiTNFα
not treated by antiTNFαOther
pregnant IBD women not treated by antiTNFα
| Study group | Role | What they receive |
|---|---|---|
| pregnant IBD women treated | pregnant IBD women treated by antiTNFα Receives: Other: treated by antiTNFα | |
| pregnant IBD women not treated | pregnant IBD women not treated by antiTNFα Receives: Other: not treated by antiTNFα |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complications
composite criteria composed by:
- Disease related complications
- Treatment related complications
- Pregnancy related complications
Measured: 9 months
Secondary outcomes (1)
Infectious Complications in the children born from IBD mothers
Occurrence of infectious complications during the first year of life
Measured: The first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startMar 2016
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 8,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134508
- Sponsor's protocol ID
- LUU AOI 2016
- Acronym
- EVASION
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2017
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luu M, Benzenine E, Doret M, Michiels C, Barkun A, Degand T, Quantin C, Bardou M. Continuous Anti-TNFalpha Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus. A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol. 2018 Nov;113(11):1669-1677. doi: 10.1038/s41395-018-0176-7. Epub 2018 Jul 2.
PubMed 29961771
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database
- ClinicalTrials.gov ID
- NCT03134508
- Acronym / sponsor ID
- EVASION / LUU AOI 2016
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,726 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2017 (actual)
- 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.
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant IBD women treated | – | Other: treated by antiTNFαpregnant IBD women treated by antiTNFα |
| pregnant IBD women not treated | – | Other: not treated by antiTNFαpregnant IBD women not treated by antiTNFα |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women with a diagnosis of IBD
Key inclusion criteria (2 listed)
- pregnancy between 01/01/2011 and 31/12/2014
- Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)
Key exclusion criteria (1 listed)
- Non IBD indication of antiTNFα treatment
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 |
|---|---|---|
| treated by antiTNFαpregnant IBD women treated by antiTNFα | Other | pregnant IBD women treated |
| not treated by antiTNFαpregnant IBD women not treated by antiTNFα | Other | pregnant IBD women not treated |
Primary outcome
Overall complications
Time frame: 9 months
composite criteria composed by: * Disease related complications * Treatment related complications * Pregnancy related complications
1 secondary outcome
Infectious Complications in the children born from IBD mothers
Time frame: The first year of life
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 12 Mar 2026.
- Results publication: PubMed 29961771Luu M, Benzenine E, Doret M, Michiels C, Barkun A, Degand T, Quantin C, Bardou M. Continuous Anti-TNFalpha Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus. A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol. 2018 Nov;113(11):1669-1677. doi: 10.1038/s41395-018-0176-7. Epub 2018 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Overall complications (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134508, which also lists 1 linked publication.
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 12 Mar 2026.