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

NCT02998398 | Completed

• 2 other identifiers: NI-16-0042016-A02016-A00700-51
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Spondyloarthritis; Crohn's Disease; Uveitis

Keywords

Biosimilar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Interventions

Switch from REMICADE® to INFLECTRA® OTHER

Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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®

You may not qualify if:

• none

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, Paris, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 29102156 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis; Crohn Disease; Uveitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Uveal Diseases; Eye Diseases

Study Officials

• Maxime DOUGADOS, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: December 20, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 29, 2016
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)