A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04804540
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Takeda
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