Colitis, UlcerativeNCT02678052
OTIS Vedolizumab Pregnancy Exposure Registry
An observational study of Colitis, Ulcerative and Crohn's Disease, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colitis, Ulcerative, Crohn's Disease
- What is being tested?
- Vedolizumab and Other Biological Agent
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 31 Jul 2022
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant woman with or without UC or CD with exposure to Entyvio or any other biological agent (only for women with UC or CD) during pregnancy will be observed in this study.
Who may be able to join
- For the UC/CD Prospective Cohort:
- Is a currently pregnant woman with UC or CD,
- Has exposure to Entyvio or other biologic agents at any dose, and at any time from first day of LMP,
- Has enrolled no later than 19 completed weeks after LMP.
- Agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.
- For the 'no chronic disease' Prospective Cohort:
Show all 10Show fewer
- Is a currently pregnant woman with no chronic disease.
- Has no exposure to any biological agent and at any time from first day of LMP,
- Has enrolled no later than 19 completed weeks after LMP.
- Agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.
Who cannot join
- For the UC/CD Prospective Cohort:
- Is greater than (>) 19 completed weeks gestation prior to enrollment,
- Has first contact with OTIS after prenatal diagnosis of any major structural defect,
- Has enrolled in this registry with a previous pregnancy,
- Has had an exposure to the known or suspected human teratogens: Chlorambucil. Cyclophosphamide, Mycophenylate mofetil.
- For the 'no chronic disease' Prospective Cohort:
Show all 11Show fewer
- Is >19 completed weeks gestation prior to enrollment,
- Has first contact with OTIS after prenatal diagnosis of any major structural defect,
- Has enrolled in this registry with a previous pregnancy,
- Has had an exposure to the known or suspected human teratogens: Chlorambucil, Cyclophosphamide, Mycophenylate mofetil.
- Note: women exposed to Entyvio during pregnancy but not meeting the above criteria can enroll into the Entyvio pregnancy exposure case series component of this registry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents.
Read the detailed description
The drug being observed in this study is called Vedolizumab. Vedolizumab is approved for the treatment of adult participants with moderately to severely active UC and CD who achieved an inadequate response, had a loss of response, or were intolerant to conventional and/or biologic treatments. This study will look at any possible association between vedolizumab and pregnancy outcome, including the health of the mother, fetus, and infant in the female with planned and unplanned pregnancies and who are at least 1 dose exposed at any time from last menstrual period (LMP) during pregnancy to vedolizumab (Entyvio) or other biological agents for UC or CD.
The study will enroll approximately 200 pregnant female participants drawn from 3 sources: OTIS Network, pregnant women who spontaneously contact the study research center or the sponsor or who are referred by their health care practitioners (HCP) in North America and women in North America who become pregnant while participating in other Entyvio clinical studies being undertaken by the sponsor. Participants will be assigned to one of the two cohorts:
- No chronic disease prospective cohort
- UC/CD prospective cohort All participants will be observed throughout the study. All participants will be asked to record all medications (including dose, frequency, and route), any additional exposures or events as the pregnancy progresses in a pregnancy diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 6 years. Cohort enrollment will be done before 20 weeks of gestation period and intake interviews would be scheduled telephonically. Schedule of intake interviews of participants will depends upon the duration of LMP prior to enrollment of participants in study. Outcome interview would be conducted within 0 to 6 weeks after delivery, dysmorphological examination of live infants would be conducted within 0 to 12 months after delivery and pediatric medical record review and questionnaire would be held 1 year after delivery.
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Being tested
- Vedolizumab, Other Biological Agent
- Keywords
- Drug therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Also called Entyvio
Vedolizumab exposure
Other Biological AgentBiological
Other Biological Agent exposure
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: No Chronic Disease | Pregnant women without a current diagnosis of any chronic disease with no exposure to any biological agent and at any time from first day of last menstrual period (LMP) will be observed for up to 1 year. | |
| Cohort 2: UC/CD Prospective Cohort | Pregnant women with current diagnosis of UC or CD with exposure to Entyvio or other biologic agents during pregnancy at any dose, and at any time from first day of LMP will be observed for up to 1 year. Receives: Drug: Vedolizumab; Biological: Other Biological Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Structural Birth Defects Identified in Infants After Birth
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC). These defects in aggregate typically occur in less than (<) 4% of the general population. Over 100 specific structural defects are considered to be major. Baseline will be considered as the time of birth of child.
Measured: Baseline up to 1 year
Secondary outcomes (1)
Minor Structural Birth Defects Identified in Infants After Birth
A minor structural defect is defined as a defect that has neither cosmetic nor functional significance to the child (for example: complete 2,3 syndactyly of the toes) and will be identified using a study-related checklist incorporated into the study dysmorphology examination of live born infants. Baseline will be considered at the time of birth of child.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start1 Dec 2015
- Primary completion15 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, TakedaStudy Director, Study director, The Organization of Teratology Information Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678052
- Sponsor's protocol ID
- Vedolizumab-5001
- Other IDs
- EUPAS11681
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2016
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT02678052
- Acronym / sponsor ID
- Vedolizumab-5001
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 9 Feb 2016 (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 to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents.
Detailed description
The drug being observed in this study is called Vedolizumab. Vedolizumab is approved for the treatment of adult participants with moderately to severely active UC and CD who achieved an inadequate response, had a loss of response, or were intolerant to conventional and/or biologic treatments. This study will look at any possible association between vedolizumab and pregnancy outcome, including the health of the mother, fetus, and infant in the female with planned and unplanned pregnancies and who are at least 1 dose exposed at any time from last menstrual period (LMP) during pregnancy to vedolizumab (Entyvio) or other biological agents for UC or CD.
The study will enroll approximately 200 pregnant female participants drawn from 3 sources: OTIS Network, pregnant women who spontaneously contact the study research center or the sponsor or who are referred by their health care practitioners (HCP) in North America and women in North America who become pregnant while participating in other Entyvio clinical studies being undertaken by the sponsor. Participants will be assigned to one of the two cohorts:
- No chronic disease prospective cohort
- UC/CD prospective cohort All participants will be observed throughout the study. All participants will be asked to record all medications (including dose, frequency, and route), any additional exposures or events as the pregnancy progresses in a pregnancy diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 6 years. Cohort enrollment will be done before 20 weeks of gestation period and intake interviews would be scheduled telephonically. Schedule of intake interviews of participants will depends upon the duration of LMP prior to enrollment of participants in study. Outcome interview would be conducted within 0 to 6 weeks after delivery, dysmorphological examination of live infants would be conducted within 0 to 12 months after delivery and pediatric medical record review and questionnaire would be held 1 year after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: No Chronic Disease | – | –Pregnant women without a current diagnosis of any chronic disease with no exposure to any biological agent and at any time from first day of last menstrual period (LMP) will be observed for up to 1 year. |
| Cohort 2: UC/CD Prospective Cohort | – | Drug: Vedolizumab, Biological: Other Biological AgentPregnant women with current diagnosis of UC or CD with exposure to Entyvio or other biologic agents during pregnancy at any dose, and at any time from first day of LMP will be observed for up to 1 year. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant woman with or without UC or CD with exposure to Entyvio or any other biological agent (only for women with UC or CD) during pregnancy will be observed in this study.
Key inclusion criteria (10 listed)
- Is a currently pregnant woman with UC or CD,
- Has exposure to Entyvio or other biologic agents at any dose, and at any time from first day of LMP,
- Has enrolled no later than 19 completed weeks after LMP.
- Agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.
- Is a currently pregnant woman with no chronic disease.
Key exclusion criteria (11 listed)
- Is greater than (>) 19 completed weeks gestation prior to enrollment,
- Has first contact with OTIS after prenatal diagnosis of any major structural defect,
- Has enrolled in this registry with a previous pregnancy,
- Has had an exposure to the known or suspected human teratogens: Chlorambucil. Cyclophosphamide, Mycophenylate mofetil.
- Is >19 completed weeks gestation prior to enrollment,
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 |
|---|---|---|
| VedolizumabAlso: EntyvioVedolizumab exposure | Drug | Cohort 2: UC/CD Prospective Cohort |
| Other Biological AgentOther Biological Agent exposure | Biological | Cohort 2: UC/CD Prospective Cohort |
Primary outcome
Major Structural Birth Defects Identified in Infants After Birth
Time frame: Baseline up to 1 year
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC). These defects in aggregate typically occur in less than (<) 4% of the general population. Over 100 specific structural defects are considered to be major. Baseline will be considered as the time of birth of child.
1 secondary outcome
Minor Structural Birth Defects Identified in Infants After Birth
Time frame: Baseline up to 1 year
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 8 Oct 2024.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
Study Director study director
The Organization of Teratology Information Specialists
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 Colitis, Ulcerative and Crohn's Disease, run by Takeda at 1 site in United States.
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 10 inclusion and 11 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 8 Oct 2024. 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 United States. 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?
Major Structural Birth Defects Identified in Infants After Birth (time frame: Baseline up to 1 year). 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 8 Oct 2024.