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Biosimilar switch works for most patients in Real-World study

NCT ID NCT02998398

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested what happens when patients with rheumatoid arthritis, Crohn's disease, or eye inflammation switch from the original drug Remicade to its lower-cost biosimilar Inflectra. Over 260 adults who had been on Remicade for at least 4 months were switched. The main goal was to see how many stayed on Inflectra after three doses. Results help doctors understand if switching is a safe and effective option in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
biosimilar infliximab (Inflectra)
What this could lead to
If successful, this could show that switching to a biosimilar is safe and effective, potentially lowering treatment costs for patients with inflammatory diseases.
What could go wrong
This is a small, single-hospital study without a comparison group. Results may not apply to all patients, and some may experience disease flares or develop antibodies after switching.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

262 people

The number who actually took part.

Started

Oct 2015

Finished

Jun 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease rheumatoid arthritis Spondylarthritis spondyloarthropathy uveitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Rheumatoid arthritis Spondyloarthritis Uveitis

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.