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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Rheumatoid Arthritis, Spondyloarthritis, Crohn's Disease, Uveitis

Intervention / Treatment
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* Other: Switch from REMICADE® to INFLECTRA®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Switch 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|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infliximab serum level |  | after the third infusion of INFLECTRA®, up to 24 weeks | 
| Percentage of patients with a flare of their disease | The flare will be assessed by usual physiological parameter of the disease | after the third infusion of INFLECTRA®, up to 24 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosimilar