drugset / Trial / NCT02452151

"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"

NCT02452151

Phase 4 Unknown 300 enrolled Onze Lieve Vrouwe Gasthuis Santeon · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.

Timeline

Start
2015-08
Primary completion
2016-08
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infliximab Monoclonal antibody 5 mg/kg Intravenous
Comparator Infliximab Monoclonal antibody 10 mg/kg Intravenous