Crohn's DiseaseNCT02862132
Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
A study testing Vedolizumab in people with Crohn's Disease and Ulcerative Colitis, run by Shaare Zedek Medical Center at 15 sites in 6 countries.
Trial summary
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut. Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel 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
- 142 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Jan 2017to Jan 2022
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children under the age of 18 years.
- IBD Diagnosis
- Initiating Vedolizumab therapy
Who cannot join
- 1. Starting Vedolizumab to prevent post operative recurrence
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Israel7 sites
Rambam Medical Cener
Haifa
Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem
Schneider Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Ichilov
Tel Aviv
Assaf Harofeh
Tzrifin
United States4 sites
Connecticut Children's Medical Center
Hartford, Connecticut, 06032
Atlantic Children's Health-Goryeb Children's Hospital
Morristown, New Jersey
Cohen Children's Medical Center of NY, Northwell
New York, New York
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
About this study
Official title: Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut.
Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively.
Read more
Recent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series.
Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children.
The investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.
Read the detailed description
This is a multi-center prospective cohort study in which the investigators are aim to enroll 140 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 70 in UC/IBDU and 70 in the CD group) who commenced on Vedolizumab for any reason at the discretion of the treating physician.
Patients will be followed up to 3 years at 8 different time points: week 0, week 2, week 6, week 14, week 30, week 54 (1 year), week 108 (2 years) and week 162 (3 years). Blood work will be collected at each visit during the time of venous access insertion for the drug infusion for serum and stool sample will be collected at visits 0, 14, 30, and 54. In addition, at week 0 and 14 whole blood will be collected into a PaxGene tube for gene expression analysis.
- Being tested
- Vedolizumab
- Keywords
- VDZ: Vedolizumab, UC: Ulcerative colitis, CD: Crohn's disease, TDM: Therapeutic drug monitoring
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Also called Entyvio
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab | Experimental | IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission at week 14
As defined by all three criteria:
- Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Measured: weeks 14
Complete remission at week 30
As defined by all three criteria:
- Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Measured: weeks 30
Complete remission at week 54
As defined by all three criteria:
- Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Measured: weeks 54
Complete remission at week 108
As defined by all three criteria:
- Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Measured: weeks 108
Complete remission at week 162
As defined by all three criteria:
- Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Measured: weeks 162
Secondary outcomes (12)
Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.
Measured: week 30, week 54, week 108, week 162
Steroid and EEN free clinical response (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.
Measured: week 30, week 54, week 108, week 162
Fecal calprotectin levels
Levels of calprotectin will be measured in the lab using calprotectin kit.
Measured: week 30, week 54, week 108, week 162
serum CRP levels
CRP levels will be measured in the lab
Measured: week 30, week 54, week 108, week 162
Rate of loss of response including drug levels
Measured: week 30, week 54, week 108, week 162
Steroid dependency (defined as cumulative use of >4 months in a year with at least one need to increase dose while weaning)
Measured: week 30, week 54, week 108, week 162
Adverse events
Measured: week 30, week 54, week 108, week 162
Measures of mucosal inflammation as available as part of clinical care using endoscopy, imaging or capsule endoscopy.
Measured: week 30, week 54, week 108, week 162
Time to induction of remission
Measured: week 30, week 54, week 108, week 162
Longitudinal Physician Global Assessment (PGA)
PGA will be measured using Visual analogue scale (VAS)
Measured: week 30, week 54, week 108, week 162
Height velocity as compared with the year prior to commencing VDZ
Measured: week 30, week 54, week 108, week 162
Need for surgical interventions (including resections, colectomy, and dilatations)
Measured: week 30, week 54, week 108, week 162
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dan Turner, Shaare Zedek Medical Center
- Investigators
- Dan Turner, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862132
- Sponsor's protocol ID
- VEDOKIDS
- Status last verified
- Oct 2022
- First submitted
- 31 Jul 2016
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
D'Arcangelo G, Turner D, Ledder O, Orlanski-Meyer E, Broide E, Granot M, Matar M, Hussey S, Yerushalmy-Feler A, Norden C, Miele E, Aloi M. Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):495-502. doi: 10.1002/jpn3.70276. Epub 2025 Nov 18.
PubMed 41251034Atia O, Shavit-Brunschwig Z, Lev-Tzion R, Stein R, Broide E, Urlep D, Hyams J, Weiss B, Aloi M, Assa A, Gerasimidis K, Nichols B, Russell RK, Turner D. Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):234-247. doi: 10.1016/S2468-1253(24)00319-4. Epub 2025 Jan 6.
PubMed 39788134Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):31-42. doi: 10.1016/S2468-1253(22)00307-7. Epub 2022 Oct 26.
PubMed 36306803
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
- ClinicalTrials.gov ID
- NCT02862132
- Acronym / sponsor ID
- VEDOKIDS
- Keywords
- VDZ: Vedolizumab, UC: Ulcerative colitis, CD: Crohn's disease, TDM: Therapeutic drug monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 10 Aug 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.
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut.
Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively.
Recent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series.
Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children.
The investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.
Detailed description
This is a multi-center prospective cohort study in which the investigators are aim to enroll 140 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 70 in UC/IBDU and 70 in the CD group) who commenced on Vedolizumab for any reason at the discretion of the treating physician.
Patients will be followed up to 3 years at 8 different time points: week 0, week 2, week 6, week 14, week 30, week 54 (1 year), week 108 (2 years) and week 162 (3 years). Blood work will be collected at each visit during the time of venous access insertion for the drug infusion for serum and stool sample will be collected at visits 0, 14, 30, and 54. In addition, at week 0 and 14 whole blood will be collected into a PaxGene tube for gene expression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab | Experimental | Drug: VedolizumabIV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children under the age of 18 years.
- IBD Diagnosis
- Initiating Vedolizumab therapy
Key exclusion criteria (1 listed)
- 1. Starting Vedolizumab to prevent post operative recurrence
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 | Drug | Vedolizumab |
Primary outcome
Complete remission at week 14
Time frame: weeks 14
As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Complete remission at week 30
Time frame: weeks 30
As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Complete remission at week 54
Time frame: weeks 54
As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Complete remission at week 108
Time frame: weeks 108
As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
Complete remission at week 162
Time frame: weeks 162
As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as >50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) <10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)
12 secondary outcomes
Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.
Time frame: week 30, week 54, week 108, week 162
Steroid and EEN free clinical response (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.
Time frame: week 30, week 54, week 108, week 162
Fecal calprotectin levels
Time frame: week 30, week 54, week 108, week 162
serum CRP levels
Time frame: week 30, week 54, week 108, week 162
Rate of loss of response including drug levels
Time frame: week 30, week 54, week 108, week 162
Steroid dependency (defined as cumulative use of >4 months in a year with at least one need to increase dose while weaning)
Time frame: week 30, week 54, week 108, week 162
Adverse events
Time frame: week 30, week 54, week 108, week 162
Measures of mucosal inflammation as available as part of clinical care using endoscopy, imaging or capsule endoscopy.
Time frame: week 30, week 54, week 108, week 162
Time to induction of remission
Time frame: week 30, week 54, week 108, week 162
Longitudinal Physician Global Assessment (PGA)
Time frame: week 30, week 54, week 108, week 162
Height velocity as compared with the year prior to commencing VDZ
Time frame: week 30, week 54, week 108, week 162
Need for surgical interventions (including resections, colectomy, and dilatations)
Time frame: week 30, week 54, week 108, week 162
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 25 Oct 2022.
- Derived from this study: PubMed 41251034D'Arcangelo G, Turner D, Ledder O, Orlanski-Meyer E, Broide E, Granot M, Matar M, Hussey S, Yerushalmy-Feler A, Norden C, Miele E, Aloi M. Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):495-502. doi: 10.1002/jpn3.70276. Epub 2025 Nov 18.
- Derived from this study: PubMed 39788134Atia O, Shavit-Brunschwig Z, Lev-Tzion R, Stein R, Broide E, Urlep D, Hyams J, Weiss B, Aloi M, Assa A, Gerasimidis K, Nichols B, Russell RK, Turner D. Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):234-247. doi: 10.1016/S2468-1253(24)00319-4. Epub 2025 Jan 6.
- Derived from this study: PubMed 36306803Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):31-42. doi: 10.1016/S2468-1253(22)00307-7. Epub 2022 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
Dan Turner, MD principal investigator
Shaare Zedek Medical Center
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vedolizumab in people with Crohn's Disease and Ulcerative Colitis, run by Shaare Zedek Medical Center at 15 sites in 6 countries.
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 3 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Israel, United States, Denmark, Ireland, Slovenia and 1 more country. 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?
Complete remission at week 14 (time frame: weeks 14). The study lists 5 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 NCT02862132, which also lists 3 linked publications.
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 25 Oct 2022.