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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR INFLECTRA


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Biosimilar Clinical Trials for INFLECTRA

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT02452151 ↗ "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" Unknown status Santeon Phase 4 2015-08-01 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.
NCT02452151 ↗ "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" Unknown status Onze Lieve Vrouwe Gasthuis Phase 4 2015-08-01 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.
NCT02539368 ↗ Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease Completed Hospira, Inc. 2015-04-22 This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for INFLECTRA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02452151 ↗ "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" Unknown status Santeon Phase 4 2015-08-01 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.
NCT02452151 ↗ "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" Unknown status Onze Lieve Vrouwe Gasthuis Phase 4 2015-08-01 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.
NCT02517684 ↗ Top-down Infliximab Study in Kids With Crohn's Disease Active, not recruiting Hospira, Inc. Phase 4 2015-04-01 The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for INFLECTRA

Condition Name

Condition Name for INFLECTRA
Intervention Trials
Crohn's Disease 3
Crohn Disease 2
Child, Only 1
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Condition MeSH

Condition MeSH for INFLECTRA
Intervention Trials
Crohn Disease 5
Intestinal Diseases 2
Inflammatory Bowel Diseases 2
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Clinical Trial Locations for INFLECTRA

Trials by Country

Trials by Country for INFLECTRA
Location Trials
Spain 9
United Kingdom 9
Italy 7
United States 7
Canada 7
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Trials by US State

Trials by US State for INFLECTRA
Location Trials
California 2
Wisconsin 1
Ohio 1
Indiana 1
Florida 1
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Clinical Trial Progress for INFLECTRA

Clinical Trial Phase

Clinical Trial Phase for INFLECTRA
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for INFLECTRA
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for INFLECTRA

Sponsor Name

Sponsor Name for INFLECTRA
Sponsor Trials
Hospira, Inc. 3
Hospira, now a wholly owned subsidiary of Pfizer 3
Erasmus Medical Center 2
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Sponsor Type

Sponsor Type for INFLECTRA
Sponsor Trials
Industry 8
Other 7
NIH 1
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