Colitis, UlcerativePhase 4NCT02559713
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
A Phase 4 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn's Disease, run by Takeda at 7 sites in United States.
Trial summary
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colitis, Ulcerative, Crohn's Disease
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Nov 2017to 22 Feb 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is capable of understanding and complying with protocol requirements.
- Signs and dates as written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is female and at least 18 years of age at the time of informed consent.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
- Is on established vedolizumab maintenance therapy and received at least 1 dose of 300 mg of vedolizumab IV postpartum or has completed vedolizumab induction therapy (300 mg of vedolizumab IV at Week 0, Week 2, and Week 6), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
- Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a mother-infant pair is required.
Show all 11Show fewer
- Is at least 5 weeks postpartum by Day 1.
- Lactation is well established, and the mother is exclusively breast feeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
- Participant has independently decided to be treated with vedolizumab or to breastfeed prior to providing consent to participate in this study.
- Plans to continue breastfeeding at least throughout the duration of this study.
- Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period.
Who cannot join
- Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
- Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
- Nonbiologic therapies [example (eg), cyclosporine], other than those listed in the protocol.
- An approved nonbiologic therapy in an investigational protocol.
- Has received any live vaccinations within 30 days prior to vedolizumab administration.
- Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
Show all 19Show fewer
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or allergic skin rash that, in the opinion of the investigator, would confound the study results or compromise participant safety. Additionally, if there is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug that might interfere with the conduct of the study.
- Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
- Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (eg, greater than (>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
- Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
- Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist at screening.
- Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
- Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
- Is unable to participate in all the study visits or comply with study procedures.
- Has history of breast implants, breast augmentation, or breast reduction surgery.
- Has a prior history of difficulty establishing lactation.
- Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
- Has donated or lost 450 milliliters or more of her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado
Aurora, Colorado, 80045
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Feinberg School of Medicine Northwestern University
Chicago, Illinois, 60637
Baylor College of Medicine
Houston, Texas, 77030
Atlantic Health System
Morristown, New Jersey, 07960
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1150
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
Read the detailed description
The drug being tested in this study is called vedolizumab. This post-marketing milk-only lactation study will assess concentrations of vedolizumab in breast milk of lactating women with active UC or CD who are receiving vedolizumab therapeutically.
The study will enroll approximately 12 participants. All participants who received an established vedolizumab maintenance regimen or has completed induction therapy for the treatment of active UC or CD.
30-minute IV infusion of 300 mg vedolizumab. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 3 months. Participants will make visits to clinic, study site or HCP office at Screening, Check-in (Day -1). Visits on Days 4, 8, 15, or 29 may be completed at the participant's home setting in the presence of a qualified nurse, or at a clinic, study site or other HCP office. The study exit/follow-up safety assessment will occur on Day 57(±3).
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Being tested
- Vedolizumab
- Keywords
- Lactation, Lactating Women, Vedolizumab, Colitis Ulcerative, Crohn's Disease, Crohn's
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Also called Entyvio, MLN0002
Vedolizumab IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300 milligram (mg) | Experimental | Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1. Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Vedolizumab in Breast Milk at Predose on Day 1
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 1 (60 minutes prior to the start of infusion)
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 1 (approximately 60 minutes after the end of infusion)
Concentration of Vedolizumab in Breast Milk on Day 4
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 4
Concentration of Vedolizumab in Breast Milk on Day 8
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 8
Concentration of Vedolizumab in Breast Milk on Day 15
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 15
Concentration of Vedolizumab in Breast Milk on Day 29
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Measured: Day 29
Concentration of Vedolizumab in Breast Milk on Day 57
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk in participants with analysis of vedolizumab concentration from the pooled milk sample was done by ELISA.
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start29 Nov 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559713
- Sponsor's protocol ID
- Vedolizumab-4001
- Other IDs
- U1111-1171-5296
- Status last verified
- Dec 2020
- First submitted
- 23 Sep 2015
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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.
Publications
Sun W, Fennimore B, Beaulieu DB, Arsenescu R, Stein AC, Chen J, Lin T, McKnight S, Kadali H, Rosario M, Lirio RA. Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease. Clin Pharmacokinet. 2021 Jun;60(6):811-818. doi: 10.1007/s40262-021-00985-4. Epub 2021 Feb 5.
PubMed 33544318
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically
- ClinicalTrials.gov ID
- NCT02559713
- Acronym / sponsor ID
- Vedolizumab-4001
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Keywords
- Lactation, Lactating Women, Vedolizumab, Colitis Ulcerative, Crohn's Disease, Crohn's
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Posted 4 Mar 2020
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 concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
Detailed description
The drug being tested in this study is called vedolizumab. This post-marketing milk-only lactation study will assess concentrations of vedolizumab in breast milk of lactating women with active UC or CD who are receiving vedolizumab therapeutically.
The study will enroll approximately 12 participants. All participants who received an established vedolizumab maintenance regimen or has completed induction therapy for the treatment of active UC or CD.
30-minute IV infusion of 300 mg vedolizumab. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 3 months. Participants will make visits to clinic, study site or HCP office at Screening, Check-in (Day -1). Visits on Days 4, 8, 15, or 29 may be completed at the participant's home setting in the presence of a qualified nurse, or at a clinic, study site or other HCP office. The study exit/follow-up safety assessment will occur on Day 57(±3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300 milligram (mg) | Experimental | Drug: VedolizumabVedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is capable of understanding and complying with protocol requirements.
- Signs and dates as written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is female and at least 18 years of age at the time of informed consent.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
- Is on established vedolizumab maintenance therapy and received at least 1 dose of 300 mg of vedolizumab IV postpartum or has completed vedolizumab induction therapy (300 mg of vedolizumab IV at Week 0, Week 2, and Week 6), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
Key exclusion criteria (19 listed)
- Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
- Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
- Has received any live vaccinations within 30 days prior to vedolizumab administration.
- Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
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: Entyvio, MLN0002Vedolizumab IV infusion | Drug | Vedolizumab 300 milligram (mg) |
Primary outcome
Concentration of Vedolizumab in Breast Milk at Predose on Day 1
Time frame: Day 1 (60 minutes prior to the start of infusion)
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1
Time frame: Day 1 (approximately 60 minutes after the end of infusion)
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk on Day 4
Time frame: Day 4
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk on Day 8
Time frame: Day 8
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk on Day 15
Time frame: Day 15
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk on Day 29
Time frame: Day 29
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Concentration of Vedolizumab in Breast Milk on Day 57
Time frame: Day 57
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk in participants with analysis of vedolizumab concentration from the pooled milk sample was done by ELISA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33544318Sun W, Fennimore B, Beaulieu DB, Arsenescu R, Stein AC, Chen J, Lin T, McKnight S, Kadali H, Rosario M, Lirio RA. Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease. Clin Pharmacokinet. 2021 Jun;60(6):811-818. doi: 10.1007/s40262-021-00985-4. Epub 2021 Feb 5.
- 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.
Medical Director study director
Takeda
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn's Disease, run by Takeda at 7 sites 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 11 inclusion and 19 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of Vedolizumab in Breast Milk at Predose on Day 1 (time frame: Day 1 (60 minutes prior to the start of infusion)). The study lists 7 primary outcomes in all. 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 NCT02559713, 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 8 Jan 2021.