Back to resultsA Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Primary Purpose
Ulcerative Colitis, Crohn Disease
Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Vedolizumab IV
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of >=8 for CD at the time of enrolment.
Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
- Conventional therapy
- TNF-α alpha antagonist
Exclusion Criteria:
- Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
- Has active or latent tuberculosis (TB).
- Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Sites / Locations
- Government General Hospital
- Institute of Gastroenterology and Liver Disease Dispur Hospitals
- Indira Gandhi Institute of Medical Sciences
- Dr. Ram Manohar Lohia Hospita Hospital
- Maulana Azad Medical college & Associated G B Pant Hospital
- All India Institute of Medical Sciences
- Gastroplus Digestive Disease Centre Pvt.Ltd
- Surat Institute of Digestive Sciences
- Banglore Medical College & Research Institute
- Lakeshore Hospital and Research Centre
- Midas Multispeciality Hospital
- Dayanand Medical College and Hospital
- VGM Hospital- Institute of Gastroenterology
- Asian Institute of Gastroenterology
- Yashoda Hospitals
- King George's Medical University
- Osmania General Hospital
- Deccan College of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vedolizumab 300 mg
Arm Description
Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2 and 6 during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AEs), Serious Adverse events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs) and Unexpected ADRs
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a drug; it does not necessarily have to have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. AESIs occurs during the treatment or follow-up period, are recorded in the special interest such as opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections, malignancies, infusion-related reactions and hypersensitivity, and hepatic injury. ADRs are defined as AEs which are in the investigator's opinion of causal relationship to the study treatment. An Unexpected ADR is an ADR with the nature, severity, or outcome which is not consistent with summary of product characteristics.
Secondary Outcome Measures
Percentage of Participants with Ulcerative Colitis (UC) and Crohn's Disease (CD) Who Achieved Clinical Response
Clinical response is defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of ≥3 from baseline or by physician assessment of clinical response (UC participants) or decrease in Harvey Bradshaw Index (HBI) of ≥3 points from baseline (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and ≥5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease.
Percentage of Participants with UC and CD Who Achieved Clinical Remission
Clinical remission is defined as SCCAI of ≤2 from baseline (UC participants) or a HBI ≤4 (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and ≥5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease.
Percentage of Participants with UC and CD Who Had Vedolizumab Discontinuation
Vedolizumab discontinuation is defined as ceasing vedolizumab, or a treatment gap ≥90 days between consecutive doses.
Percentage of Participants with UC and CD Who Achieved Mucosal Healing
Mucosal healing is based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic subscore of ≤1 point or Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD ≤4 and at least a 2 point reduction from baseline with no sub-score >1. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60.
Percentage of Participants with UC and CD Who Achieved Endoscopic Response
Endoscopic response is defined as decrease in Mayo endoscopic subscore of ≥1 point in UC and >50% decrease in SES-CD in CD. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60.
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ])
The SIBDQ is a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It is a 10-item questionnaire that includes questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score is calculated by summing the scores from each domain; the total SIBDQ score ranges from 10 (poor HRQoL) to 70 (optimum HRQoL).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04804540
Brief Title
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Official Title
A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.
At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.
Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.
Detailed Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD.
The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group.
•Vedolizumab 300 mg
Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.
This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn Disease
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vedolizumab 300 mg
Arm Type
Experimental
Arm Description
Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2 and 6 during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab IV
Other Intervention Name(s)
Kynteles
Intervention Description
Vedolizumab IV infusion
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs), Serious Adverse events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs) and Unexpected ADRs
Description
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a drug; it does not necessarily have to have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. AESIs occurs during the treatment or follow-up period, are recorded in the special interest such as opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections, malignancies, infusion-related reactions and hypersensitivity, and hepatic injury. ADRs are defined as AEs which are in the investigator's opinion of causal relationship to the study treatment. An Unexpected ADR is an ADR with the nature, severity, or outcome which is not consistent with summary of product characteristics.
Time Frame
From first dose of study drug up to 6 months after the last dose of study drug (Up to approximately 70 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Ulcerative Colitis (UC) and Crohn's Disease (CD) Who Achieved Clinical Response
Description
Clinical response is defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of ≥3 from baseline or by physician assessment of clinical response (UC participants) or decrease in Harvey Bradshaw Index (HBI) of ≥3 points from baseline (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and ≥5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease.
Time Frame
Weeks 14, 30 and 46
Title
Percentage of Participants with UC and CD Who Achieved Clinical Remission
Description
Clinical remission is defined as SCCAI of ≤2 from baseline (UC participants) or a HBI ≤4 (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and ≥5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease.
Time Frame
Weeks 14, 30 and 46
Title
Percentage of Participants with UC and CD Who Had Vedolizumab Discontinuation
Description
Vedolizumab discontinuation is defined as ceasing vedolizumab, or a treatment gap ≥90 days between consecutive doses.
Time Frame
Up to 46 weeks
Title
Percentage of Participants with UC and CD Who Achieved Mucosal Healing
Description
Mucosal healing is based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic subscore of ≤1 point or Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD ≤4 and at least a 2 point reduction from baseline with no sub-score >1. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60.
Time Frame
Week 46
Title
Percentage of Participants with UC and CD Who Achieved Endoscopic Response
Description
Endoscopic response is defined as decrease in Mayo endoscopic subscore of ≥1 point in UC and >50% decrease in SES-CD in CD. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60.
Time Frame
Week 46
Title
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ])
Description
The SIBDQ is a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It is a 10-item questionnaire that includes questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score is calculated by summing the scores from each domain; the total SIBDQ score ranges from 10 (poor HRQoL) to 70 (optimum HRQoL).
Time Frame
From Baseline and Weeks 14, 30 and 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of >=8 for CD at the time of enrolment.
Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
Conventional therapy
TNF-α alpha antagonist
Exclusion Criteria:
Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
Has active or latent tuberculosis (TB).
Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Government General Hospital
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Facility Name
Institute of Gastroenterology and Liver Disease Dispur Hospitals
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781006
Country
India
Facility Name
Indira Gandhi Institute of Medical Sciences
City
Patna
State/Province
Bihar
ZIP/Postal Code
800014
Country
India
Facility Name
Dr. Ram Manohar Lohia Hospita Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Maulana Azad Medical college & Associated G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Gastroplus Digestive Disease Centre Pvt.Ltd
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Surat Institute of Digestive Sciences
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Banglore Medical College & Research Institute
City
Bangalore
State/Province
Karnatka
ZIP/Postal Code
560002
Country
India
Facility Name
Lakeshore Hospital and Research Centre
City
Kochi
State/Province
Kerla
ZIP/Postal Code
682040
Country
India
Facility Name
Midas Multispeciality Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
VGM Hospital- Institute of Gastroenterology
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641005
Country
India
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Facility Name
Yashoda Hospitals
City
Secunderabad
State/Province
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Osmania General Hospital
City
Hyderabad
ZIP/Postal Code
500012
Country
India
Facility Name
Deccan College of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500058
Country
India
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/5f6b60394db2bf003ab4a247
Description
Related Info
Learn more about this trial
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
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