drugset / Trial / NCT02611817

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

NCT02611817

Phase 3 Completed 644 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Timeline

Start
2016-01-04
Primary completion
2019-05-06
Completion
2019-08-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 108 mg Subcutaneous
Subject Vedolizumab Monoclonal antibody 300 mg Subcutaneous

Indications