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

April 30, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital COCHIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients continuing INFLECTRA®
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
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
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with a flare of their disease
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
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®
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®
Time Frame: after the last infusion of REMICADE®, up to 24 weeks
after the last infusion of REMICADE®, up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Maxime DOUGADOS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 29, 2016

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-16-004
  • 2016-A02016-A00700-51 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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