Determination of the Optimal Treatment Target in Ulcerative Colitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colitis Ulcerative
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: In this study, participants with active UC will be randomized in a 2:3:5 ratio to 1 of 3 treatment target groups. Participants will be assigned a treatment algorithm based on their existing UC treatment at time of entry. Treatment algorithms may include the use of vedolizumab. A key premise is that vedolizumab has a favorable safety profile and can be used to treat subjects who are in symptomatic remission but who have not attained endoscopic or histopathologic remission. Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm.Masking: Single (Participant)Masking Description: Investigators will be trained on the treatment algorithms and target groups. Study participants will be blinded to target group assignment, whereas investigators will be unblinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04259138
- Collaborators
- Takeda Development Center Americas, Inc.
- Investigators
- Principal Investigator: Vipul Jairath, MD Alimentiv Inc.
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