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

NCT ID: NCT02998398

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 262 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-29

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

Conditions

Rheumatoid Arthritis; Spondyloarthritis; Crohn's Disease; Uveitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime DOUGADOS, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Cochin

Paris, Paris, France

Countries

France

References

Avouac J, Molto A, Abitbol V, Etcheto A, Salcion A, Gutermann L, Klotz C, Elhai M, Cohen P, Soret PA, Morin F, Conort O, Chast F, Goulvestre C, Jeunne CL, Chaussade S, Kahan A, Roux C, Allanore Y, Dougados M. Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France. Semin Arthritis Rheum. 2018 Apr;47(5):741-748. doi: 10.1016/j.semarthrit.2017.10.002. Epub 2017 Oct 5.

Reference Type: RESULT

PMID: 29102156 (View on PubMed)

Other Identifiers

2016-A02016-A00700-51

Identifier Type: OTHER

Identifier Source: secondary_id

NI-16-004

Identifier Type: -

Identifier Source: org_study_id