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Santeon InflixMab biosimILAr Research A Randomized, Controlled, Double Blind, Phase 4 Noninferiority Trial to Assess Efficacy of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission. (SIMILAR)
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.
Details
| Lead sponsor | Onze Lieve Vrouwe Gasthuis |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 300 |
| Start date | 2015-08 |
| Completion | 2016-09 |
Conditions
- Colitis, Ulcerative
- Crohn's Disease
Interventions
- Infliximab-Biosimilar
- Infliximab-Innovator
Primary outcomes
- Relapse rate — 3 months
Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the relapse rate for each diagnosis seperately. - Duration of clinical remission — 3 months
Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the the duration of clinical remission for each diagnosis seperately.