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

Completed

• Conditions: Rheumatoid Arthritis; Spondyloarthritis; Crohn's Disease; Uveitis

• Registration Number: NCT02998398
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-17
• Primary Completion: 2016-06
• Study Completion: 2016-06-29
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France