Rheumatoid ArthritisSICNCT02998398
Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Crohn's Disease
- What is being tested?
- Switch from REMICADE® to INFLECTRA®
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to 29 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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®
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) 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
Read the 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
- Being tested
- Switch from REMICADE® to INFLECTRA®
- Keywords
- Biosimilar
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Crohn Disease, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients continuing INFLECTRA®
Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion
Measured: after the third infusion of INFLECTRA®, up to 24 weeks
Secondary outcomes (4)
Infliximab serum level
Measured: after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with a flare of their disease
The flare will be assessed by usual physiological parameter of the disease
Measured: after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®
Measured: after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®
Measured: after the last infusion of REMICADE®, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completion29 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Maxime DOUGADOS, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998398
- Sponsor's protocol ID
- NI-16-004
- Other IDs
- 2016-A02016-A00700-51
- Acronym
- SIC
- Status last verified
- Jan 2026
- First submitted
- 17 May 2016
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29102156
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital
- ClinicalTrials.gov ID
- NCT02998398
- Acronym / sponsor ID
- SIC / NI-16-004
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Crohn's Disease, Uveitis
- Keywords
- Biosimilar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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®
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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
4 secondary outcomes
Infliximab serum level
Time frame: after the third infusion of INFLECTRA®, up to 24 weeks
Percentage of patients with a flare of their disease
Time frame: after the third infusion of INFLECTRA®, up to 24 weeks
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 29102156Avouac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime DOUGADOS, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients continuing INFLECTRA® (time frame: after the third infusion of INFLECTRA®, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.