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

Rheumatoid Arthritis Clinical Trial

— SIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998398
• Other study ID #: NI-16-004
• Secondary ID: 2016-A02016-A007
• Status: Completed
• Start date: October 2015
• Est. completion date: June 29, 2016

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 29, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis
• Uveitis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infliximab serum level		after the third infusion of INFLECTRA®, up to 24 weeks
Secondary	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
Secondary	Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®		after the third infusion of INFLECTRA®, up to 24 weeks
Secondary	Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®		after the last infusion of REMICADE®, up to 24 weeks