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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participants weigh ≥10 kg at the time of screening and enrollment into the study.
The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Awards & highlights
Study Summary
This trial will help researchers learn more about the safety and effectiveness of vedolizumab in children and teenagers with Crohn's disease.
Who is the study for?
This trial is for children and teenagers with moderate to severe Crohn's disease who haven't responded well to standard treatments like corticosteroids, immunomodulators, or TNF-α antagonists. They should weigh at least 10 kg and have been diagnosed with CD at least a month prior. Participants must be up-to-date on vaccinations but can't join if they've had certain surgeries, other conditions like TB or hepatitis B/C, recent infections including COVID-19, or any history of malignancy.Check my eligibility
What is being tested?
The study tests Vedolizumab IV in young patients with Crohn's Disease. Initially, all participants receive three infusions over six weeks. Those responding will continue receiving either a high dose or low dose every eight weeks. The goal is to see if the treatment leads to remission—meaning their symptoms improve significantly or disappear entirely.See study design
What are the potential side effects?
Vedolizumab may cause side effects such as risk of infection due to weakened immune response, allergic reactions during infusion (like itching or rash), headache, joint pain, nausea and fever. Some might experience more serious issues like liver problems or progressive multifocal leukoencephalopathy (PML), a rare brain infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 10 kg.
Select...
My Crohn's disease is active and not responding to current treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Secondary outcome measures
Change from Baseline in Linear Growth Z-score
Change from Baseline in Tanner Stages at Week 54
Change from Baseline in Weight
+15 moreSide effects data
From 2020 Phase 4 trial • 278 Patients • NCT030291433%
Colitis ulcerative
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in Period
Lead-in Failure Follow-up Period
RTP: Standard Treatment Arm
RTP: VDZ Dose Optimization: Regimen A
RTP: VDZ Dose Optimization: Regimen B
Trial Design
9Treatment groups
Experimental Treatment
Group I: Maintenance Period: ≥30 kg: Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Group II: Maintenance Period: ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Group III: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Group IV: Maintenance Period: >15 to <30 kg Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group V: Maintenance Period: 10 to 15 kg Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Group VI: Maintenance Period: 10 to 15 kg Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group VII: Induction Period: ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.
Group VIII: Induction Period: >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.
Group IX: Induction Period: 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab IV
2014
Completed Phase 4
~700
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,905 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with indeterminate colitis.I weigh at least 10 kg.I've had severe colitis for over 8 years and had a colonoscopy in the last year.I've tried and not responded well to certain medications for my condition.I have not had a serious infection like pneumonia or COVID-19 in the last 30 days.I have had significant surgery on my intestines.I haven't taken any experimental or approved biologic treatments recently.I have had cancer other than some skin cancers or early-stage cervical cancer.I tested negative for hepatitis B surface antigen but positive for core antibody, and do not have hepatitis B virus DNA.I have been tested positive for hepatitis B or have immunity against it.I have signs of a genetic form of very early-onset IBD.I have a condition that weakens my immune system, such as HIV.I have been diagnosed with Crohn's disease over a month ago and it is moderately to severely active.I have chronic hepatitis C.I do not have active brain disorders or a history of serious neurological conditions.My Crohn's disease is active and not responding to current treatments.I have not received any live vaccines in the last 30 days.I need or might need surgery for Crohn's disease during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
- Group 2: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
- Group 3: Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
- Group 4: Induction Period: >15 to <30 kg, Vedolizumab 200 mg
- Group 5: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
- Group 6: Maintenance Period: ≥30 kg, Vedolizumab 300 mg
- Group 7: Induction Period: 10 to 15 kg, Vedolizumab 150 mg
- Group 8: Induction Period: ≥30 kg, Vedolizumab 300 mg
- Group 9: Maintenance Period: ≥30 kg: Vedolizumab 150 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a new study?
"As of now, there are 23 active clinical trials for Vedolizumab IV in 312 different cities across 42 countries. The first study was conducted in 2015 and involved 260 patients. It completed Phase 4 drug approval stage successfully. In the years since then, 38 more studies have been carried out."
Answered by AI
Has Vedolizumab IV received permission from the FDA for general use?
"3."
Answered by AI
Do we have a lot of data points for this research in Canada?
"Right now, this clinical trial is taking place in 26 hospitals, with locations ranging from Edmonton to Rochester. To try and limit participant burden, it is recommended you select a site close to your home."
Answered by AI
Are we looking for new participants in this experiment at the moment?
"The clinical trial is currently seeking patients that fit the study's criteria. The original posting date was April 30th, 2022 and the most recent update was on August 25th, 2022. In total, 26 different medical facilities are participating in this research project which needs a total of 120 enrollees."
Answered by AI
What other drugs have been administered in tandem with Vedolizumab IV?
"Vedolizumab IV was first researched in 2015 at AZ Delta Roeselare. Since then, there have been 38 completed clinical trials worldwide. As of now, 23 active studies are being conducted; a significant number of these are based in Edmonton, Alberta."
Answered by AI
Does this experiment have any age restrictions?
"This clinical trial is looking for pediatric patients that are older than 2 but younger than 17 years of age."
Answered by AI
How can I become a participant in this research?
"This trial is currently recruiting 120 pediatric patients that have been diagnosed with crohn disease. Key inclusion criteria for this study are as follows: The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC)., The participants weigh ≥10 kg at the time of screening and enrollment into the study., Participants with moderately to severely active Crohn's disease (CD) diagnosed at least 1 month before screening, defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 ("
Answered by AI
How many people are currently signed up for this experiment?
"That is correct, the study is currently enrolling patients. The trial was initially posted on 4/30/2022, with the most recent update being on 8/25/2022. So far, 26 sites have been recruited to help find the 120 total patients needed for the study."
Answered by AI
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