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"
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Infliximab | Monoclonal antibody | 10 mg/kg | Intravenous |