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Last Updated: September 25, 2020

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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" Not yet recruiting 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" Not yet recruiting 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 Inflectra (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease Recruiting Hospira, Inc. N/A 2015-04-01 This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra (infliximab) or Remicade (infliximab) for treatment. Inflectra 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 Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in the context of standard of care Remicade - To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD or UC - To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with Inflectra for CD or UC
NCT02539368 Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease Recruiting Pfizer N/A 2015-04-01 This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra (infliximab) or Remicade (infliximab) for treatment. Inflectra 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 Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in the context of standard of care Remicade - To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD or UC - To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with Inflectra for CD or UC
>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" Not yet recruiting 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" Not yet recruiting 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 Enrolling by invitation 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.
NCT02517684 Top-down Infliximab Study in Kids With Crohn's Disease Enrolling by invitation ZonMw: The Netherlands Organisation for Health Research and Development 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.
NCT02517684 Top-down Infliximab Study in Kids With Crohn's Disease Enrolling by invitation Erasmus Medical Center 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
Inflammatory Bowel Diseases 1
Colitis, Ulcerative 1
Ankylosing Spondylitis 1
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Condition MeSH

Condition MeSH for INFLECTRA
Intervention Trials
Crohn Disease 3
Intestinal Diseases 2
Inflammatory Bowel Diseases 2
Colitis, Ulcerative 2
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Clinical Trial Locations for INFLECTRA

Trials by Country

Trials by Country for INFLECTRA
Location Trials
Spain 6
Canada 6
Italy 6
United Kingdom 5
Finland 2
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Clinical Trial Progress for INFLECTRA

Clinical Trial Phase

Clinical Trial Phase for INFLECTRA
Clinical Trial Phase Trials
Phase 4 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for INFLECTRA
Clinical Trial Phase Trials
Recruiting 2
Enrolling by invitation 1
Not yet recruiting 1
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Clinical Trial Sponsors for INFLECTRA

Sponsor Name

Sponsor Name for INFLECTRA
Sponsor Trials
Hospira, Inc. 3
Pfizer 2
Erasmus Medical Center 1
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Sponsor Type

Sponsor Type for INFLECTRA
Sponsor Trials
Industry 5
Other 4
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