Comparing 7 approaches for ulcerative colitis
Official title: A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Interventions
Vedolizumab IV
Vedolizumab IV infusion
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Canadian Sites (4)
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital - 4480 Oak St
Vancouver, British Columbia, Canada
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baselineBaselineYour starting measurements, taken before treatment begins.Read more → for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.
- +\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohortCohortA group of participants sharing a characteristic, followed together.Read more → of this study.
- +For Treatment Cohort:
- +For ObservationalObservational studyA study that watches what happens without assigning any treatment.Read more → Cohort:
- +A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
- +A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
Exclusion
- −The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
- −For Treatment CohortCohortA group of participants sharing a characteristic, followed together.Read more → only:
- −The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- −The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would confound the study results or compromise participant safety.
- −The participant has other serious comorbidities that will limit their ability to complete the study.
- −The participant is unable to comply with all study assessments.
- −The participant is lactating or pregnant.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Vedolizumab IV, No Intervention.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 7 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 2 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 240 people.
The study is currently expected to finish around February 2033.
The main measurement is taken over: From first dose of study drug up to approximately 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Treatment CohortCohortA group of participants sharing a characteristic, followed together.Read more →: Number of Participants With at Least One Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) — measured over From first dose of study drug up to approximately 5 years.
ObservationalObservational studyA study that watches what happens without assigning any treatment.Read more → Cohort: Number of Participants With Prespecified Safety Events — measured over Up to approximately 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05442567 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Vedolizumab IVDrug
Vedolizumab IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About No InterventionOther
Participants will not receive any intervention in the Observational Cohort.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 2 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 2 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From first dose of study drug up to approximately 5 years.
The study as a whole is currently expected to finish around 2033-02-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 240 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Montreal, Quebec, Canada; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Other Sites (5)
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN
New Hyde Park, New York, United States
University of Rochester Medical Center - PPDS
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.