A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
NCT ID: NCT04804540
Last Updated: 2025-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2021-12-08
2024-02-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vedolizumab 300 mg
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.
Vedolizumab IV
Vedolizumab IV infusion
Interventions
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Vedolizumab IV
Vedolizumab IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
1. Conventional therapy
2. TNF-α alpha antagonist
Exclusion Criteria
2. Has active or latent tuberculosis (TB).
3. Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
4. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
18 Years
65 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Government General Hospital
Guntur, Andhra Pradesh, India
Institute of Gastroenterology and Liver Disease Dispur Hospitals
Guwahati, Assam, India
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Gastroplus Digestive Disease Centre Pvt.Ltd
Ahmedabad, Gujarat, India
Surat Institute of Digestive Sciences
Surat, Gujarat, India
Banglore Medical College & Research Institute
Bangalore, Karnatka, India
Midas Multispeciality Hospital
Nagpur, Maharashtra, India
Dr. Ram Manohar Lohia Hospita Hospital
New Delhi, National Capital Territory of Delhi, India
Maulana Azad Medical college & Associated G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
VGM Hospital- Institute of Gastroenterology
Coimbatore, Tamil Nadu, India
Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Yashoda Hospitals
Secunderabad, Telangana, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Osmania General Hospital
Hyderabad, , India
Deccan College of Medical Sciences
Hyderabad, , India
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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EUPAS23702
Identifier Type: OTHER
Identifier Source: secondary_id
Vedolizumab-4020
Identifier Type: -
Identifier Source: org_study_id
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