Skip to main content
OpenTrials
Completed

NCT Number: NCT02998398

Evaluation of the Switch From the Original Infliximab to Its Biosimilar 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Crohn Disease Crohn's Disease Digestive System Diseases Eye Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondyloarthritis Uveal Diseases Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cochin

Paris, 75014, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Infliximab serum level

    Time frame: after the third infusion of INFLECTRA®, up to 24 weeks

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: SIC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2016
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.