Trials / Unknown
UnknownNCT02452151
"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"
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.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Onze Lieve Vrouwe Gasthuis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infliximab-Biosimilar | |
| DRUG | Infliximab-Innovator |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2016-08-01
- Completion
- 2016-09-01
- First posted
- 2015-05-22
- Last updated
- 2015-05-22
Source: ClinicalTrials.gov record NCT02452151. Inclusion in this directory is not an endorsement.