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NCT04804540CompletedPhase 4

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
150 (actual)
First submitted
15 Mar 2021
Start date
8 Dec 2021
Primary completion date
2 Feb 2024
Lead sponsor
Takeda
NCT number
NCT04804540

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 150
  • From 8 Dec 2021 to the primary completion date, 2 Feb 2024
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Has active or latent tuberculosis (TB).

Other

  • Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gastroplus Digestive Disease Centre Pvt.Ltd
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
Banglore Medical College & Research Institute
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
VGM Hospital- Institute of Gastroenterology
Coordinator of this site? Confirm its status
CoimbatoreIndiaUnknown status
Government General Hospital
Coordinator of this site? Confirm its status
GunturIndiaUnknown status
Institute of Gastroenterology and Liver Disease Dispur Hospitals
Coordinator of this site? Confirm its status
GuwahatiIndiaUnknown status
Asian Institute Of Gastroenterology
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Osmania General Hospital
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Deccan College of Medical Sciences
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
King George's Medical University
Coordinator of this site? Confirm its status
LucknowIndiaUnknown status
Dayanand Medical College and Hospital
Coordinator of this site? Confirm its status
LudhianaIndiaUnknown status
Midas Multispeciality Hospital
Coordinator of this site? Confirm its status
NagpurIndiaUnknown status
All India Institute of Medical Sciences
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Maulana Azad Medical college & Associated G B Pant Hospital
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Dr. Ram Manohar Lohia Hospita Hospital
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Indira Gandhi Institute of Medical Sciences
Coordinator of this site? Confirm its status
PatnaIndiaUnknown status
Yashoda Hospitals
Coordinator of this site? Confirm its status
SecunderabadIndiaUnknown status
Surat Institute of Digestive Sciences
Coordinator of this site? Confirm its status
SuratIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.