Back to resultsLong-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Primary Purpose
Ulcerative Colitis, Crohn's Disease
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vedolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.
(Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
- Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.
May be receiving a therapeutic dose of the following drugs:
- Oral 5-aminosalicylic acid (5-ASA) compounds.
- Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day], budesonide at a dose <= 9 mg/day).
- Topical (rectal) treatment with 5-ASA or corticosteroids.
- Probiotics (example, Saccharomyces boulardii).
- Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
- Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
- Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
- The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
Exclusion Criteria:
- Is female and is lactating or pregnant.
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- Has withdrawn from Study MLN0002-2003.
- 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 investigator, would confound the study results or compromise participant safety.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
- Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- Has other serious comorbidities that will limit his or her ability to complete the study.
Sites / Locations
- Cedars-Sinai Medical Center
- Children's Hospital of Orange County
- University of California San Francisco
- Connecticut Children's Medical Center
- Nemours Childrens Specialty Care - Jacksonville
- Children's Center for Digestive Healthcare
- Columbia University Medical Center
- Medical Universtiry of South Carolina
- Texas Children's Hospital
- Seattle Children's Hospital
- Hopital Universitaire des Enfants Reine Fabiola
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
- Hopital Necker-Enfants Malades - Service de Gastroenterologie-Hepatologie-Nutrition Pediatriques
- BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Debreceni Egyetem Klinikai Kozpont
- The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
- Carmel Medical Center
- Shaare Zedek Medical Center
- Schneider Children's Medical Center of Israel
- Tel Aviv Sourasky Medical Center - Dept. of Gastroenterology and Hepatology
- Assaf Harofeh Medical Center
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnicki
- Uniwersytecki Szpital Dzieciecy w Krakowie
- Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
- Kharkiv Regional Clinical Children's Hospital
- Barts and The London NHS Trust - Children's Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vedolizumab High Dose Group
Vedolizumab Low Dose Group
Arm Description
Participants with UC or CD having baseline weight of greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Participants with UC or CD having baseline weight of >= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of < 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Outcomes
Primary Outcome Measures
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Secondary Outcome Measures
Percentage of Participants With UC Meeting Clinical Response Based on Complete Mayo Score at Week 32
Clinical response is defined as a continued reduction in complete mayo score of >=3 points from baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of >=1 point from baseline, or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 4 subscores: stool frequency, rectal bleeding, findings on endoscopy and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12; where higher scores indicate more severe disease.
Percentage of Participants With CD Meeting Clinical Response Based on 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32
Clinical response is defined as a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy (at initiation of MLN0002-2003) and continued reduction in CDAI that is a >=70 point decrease from the baseline Crohn's Disease Activity Index (CDAI) score at the initiation of MLN0002-2003. CDAI is a research tool used to quantify the symptoms of participants with Crohn's disease. SES-CD consists of 3 variables: ulcer size, ulcerated and affected surfaces and presence of narrowing each graded from 0 to 3 with score of 0 means no colonic lesions or mucosal healing, and SES-CD greater than (>) 1 indicates the presence of mucosal lesions.
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Major IBD-related events included hospitalizations, surgeries, or procedures due to UC and CD.
Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years
The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 8 Years
Height velocity (centimeter per year [cm/year]) is the change in height per year.
Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
BMI = Weight (in kilograms)/height^2 (in meters).
Percentage of Participants Achieving Tanner Stage V
Tanner Stage Evaluation is a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage is assessed at or before age 16 years for females or 17 years for males.
Full Information
NCT ID
NCT03196427
First Posted
June 20, 2017
Last Updated
April 28, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03196427
Brief Title
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Official Title
A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
May 26, 2025 (Anticipated)
Study Completion Date
November 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Detailed Description
The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.
This study will look at the long-term safety profile in participants who take vedolizumab IV. Participants will continue receiving the same dose assigned from the parent study MLN0002-2003 [NCT03138655], which will remain blinded until week 40.
The dosing regimen selected for the long-term study is intended to maintain clinical response at the lowest possible exposure.
At the discretion of the investigator, participants receiving the low dose (150 or 100 milligram [mg]) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).
Participants who experience continued disease worsening during the study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.
Study duration will be until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug, the participant withdraws from the study, or the sponsor decides to close the study (up to approximately 8 years).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Disease
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vedolizumab High Dose Group
Arm Type
Experimental
Arm Description
Participants with UC or CD having baseline weight of greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Arm Title
Vedolizumab Low Dose Group
Arm Type
Experimental
Arm Description
Participants with UC or CD having baseline weight of >= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of < 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
MLN0002, ENTYVIO, KYNTELES
Intervention Description
Vedolizumab intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame
Baseline up to approximately 8 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With UC Meeting Clinical Response Based on Complete Mayo Score at Week 32
Description
Clinical response is defined as a continued reduction in complete mayo score of >=3 points from baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of >=1 point from baseline, or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 4 subscores: stool frequency, rectal bleeding, findings on endoscopy and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12; where higher scores indicate more severe disease.
Time Frame
Week 32
Title
Percentage of Participants With CD Meeting Clinical Response Based on 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32
Description
Clinical response is defined as a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy (at initiation of MLN0002-2003) and continued reduction in CDAI that is a >=70 point decrease from the baseline Crohn's Disease Activity Index (CDAI) score at the initiation of MLN0002-2003. CDAI is a research tool used to quantify the symptoms of participants with Crohn's disease. SES-CD consists of 3 variables: ulcer size, ulcerated and affected surfaces and presence of narrowing each graded from 0 to 3 with score of 0 means no colonic lesions or mucosal healing, and SES-CD greater than (>) 1 indicates the presence of mucosal lesions.
Time Frame
Week 32
Title
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Description
Major IBD-related events included hospitalizations, surgeries, or procedures due to UC and CD.
Time Frame
Baseline up to approximately 8 years
Title
Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years
Description
The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
Time Frame
Baseline up to approximately 8 years
Title
Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 8 Years
Description
Height velocity (centimeter per year [cm/year]) is the change in height per year.
Time Frame
Baseline up to approximately 8 years
Title
Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Time Frame
Baseline up to approximately 8 years
Title
Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Time Frame
Baseline up to approximately 8 years
Title
Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Description
BMI = Weight (in kilograms)/height^2 (in meters).
Time Frame
Baseline up to approximately 8 years
Title
Percentage of Participants Achieving Tanner Stage V
Description
Tanner Stage Evaluation is a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage is assessed at or before age 16 years for females or 17 years for males.
Time Frame
Baseline up to approximately 8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.
(Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.
May be receiving a therapeutic dose of the following drugs:
Oral 5-aminosalicylic acid (5-ASA) compounds.
Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
Topical (rectal) treatment with 5-ASA or corticosteroids.
Probiotics (example, Saccharomyces boulardii).
Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
Exclusion Criteria:
Is female and is lactating or pregnant.
Has hypersensitivity or allergies to vedolizumab or any of its excipients.
Has withdrawn from Study MLN0002-2003.
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 investigator, would confound the study results or compromise participant safety.
Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
Has other serious comorbidities that will limit his or her ability to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Nemours Childrens Specialty Care - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Children's Center for Digestive Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
Medical Universtiry of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Hopital Universitaire des Enfants Reine Fabiola
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hopital Necker-Enfants Malades - Service de Gastroenterologie-Hepatologie-Nutrition Pediatriques
City
Paris Cedex 15
State/Province
Ile-de-france
ZIP/Postal Code
75015
Country
France
Facility Name
BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
City
Miskolc
State/Province
Borsod-abauj-zemplen
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
City
Ramat Gan
State/Province
Tel Aviv
ZIP/Postal Code
52621
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tiqwa
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center - Dept. of Gastroenterology and Hepatology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnicki
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-738
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Kharkiv Regional Clinical Children's Hospital
City
Kharkiv
ZIP/Postal Code
61093
Country
Ukraine
Facility Name
Barts and The London NHS Trust - Children's Clinical Research Facility
City
London
State/Province
Englan
ZIP/Postal Code
E1 1BB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a220?idFilter=%5B%22vedolizumab-2005%22%5D
Description
To obtain more information on the study, click on this link
Learn more about this trial
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
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