Clinical trial NCT02998398: Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital
Official title: Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Crohn's Disease
Uveitis
Keywords: Biosimilar
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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

Primary outcomes:
measure: Percentage of patients continuing INFLECTRA®
timeFrame: after the third infusion of INFLECTRA®, up to 24 weeks
Secondary outcomes:
measure: Infliximab serum level
timeFrame: after the third infusion of INFLECTRA®, up to 24 weeks
measure: Percentage of patients with a flare of their disease
timeFrame: after the third infusion of INFLECTRA®, up to 24 weeks
measure: Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®
timeFrame: after the third infusion of INFLECTRA®, up to 24 weeks
measure: Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®
timeFrame: after the last infusion of REMICADE®, up to 24 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Maxime DOUGADOS, MD, PhD
role: STUDY_CHAIR
References: