Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital

Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02998398

Acronym

SIC

Enrollment

262

Registered

2016-12-20

Start date

2015-10-31

Completion date

2016-06-29

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Rheumatoid Arthritis, Spondyloarthritis, Uveitis

Keywords

Biosimilar

Brief summary

The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition

Detailed description

All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months will be invited to continue to receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose per infusion and interval between two infusions) than the previous one while receiving REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of patients continuing INFLECTRA® after at least six months of its initiation. Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE® and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be tested. Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis, Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated according to the usual outcome measures of the activity of the disease

Interventions

OTHERSwitch from REMICADE® to INFLECTRA®

Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female over 18 year old * Patient treated with REMICADE® in Cochin hospital * More than 3 perfusions of REMICADE® before the switch to INFLECTRA®

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients continuing INFLECTRA®	after the third infusion of INFLECTRA®, up to 24 weeks	Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion

Secondary

Measure	Time frame	Description
Infliximab serum level	after the third infusion of INFLECTRA®, up to 24 weeks	—
Percentage of patients with a flare of their disease	after the third infusion of INFLECTRA®, up to 24 weeks	The flare will be assessed by usual physiological parameter of the disease
Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®	after the third infusion of INFLECTRA®, up to 24 weeks	—
Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®	after the last infusion of REMICADE®, up to 24 weeks	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026