Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

PHASE3TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

May 18, 2017

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
Ulcerative Colitis
Interventions
DRUG

Tacrolimus

Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.

DRUG

Vedolizumab

Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.

OTHER

Placebo

Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.

Trial Locations (1)

53226

Medical College of Wisconsin, Milwaukee

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Medical College of Wisconsin

OTHER