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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroplus Digestive Disease Centre Pvt.Ltd Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Banglore Medical College & Research Institute Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| VGM Hospital- Institute of Gastroenterology Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| Government General Hospital Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Institute of Gastroenterology and Liver Disease Dispur Hospitals Coordinator of this site? Confirm its status | Guwahati | India | Unknown status |
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Osmania General Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Deccan College of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| King George's Medical University Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| Dayanand Medical College and Hospital Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| Midas Multispeciality Hospital Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Maulana Azad Medical college & Associated G B Pant Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Dr. Ram Manohar Lohia Hospita Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Indira Gandhi Institute of Medical Sciences Coordinator of this site? Confirm its status | Patna | India | Unknown status |
| Yashoda Hospitals Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
| Surat Institute of Digestive Sciences Coordinator of this site? Confirm its status | Surat | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.