Arthritis, RheumatoidPERFUSENCT03662919

One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by Biogen at 60 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and… Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
What is being tested?: Infliximab and Adalimumab
How many people: 2,274 participants
Where: 60 sitesFrance
Study dates: 2 Jul 2018to 30 Jun 2022
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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants either infliximab naïve or switched from Remicade or CT-P13 to Flixabi who are treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi who are treated with Imraldi, for RA, AS, PsA, CD, and UC as prescribed by the physician in clinical practice.

Who may be able to join

Adult participant (18 years and over)
treated for one of the following conditions: RA, AS, PsA, CD, UC.
either active substance naïve or treated with the originator or another biosimilar at baseline.
for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi.
participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.
Paediatric participants (6-17 years):

Show all 10Show fewer

treated for one of the following conditions: CD, UC.
either active substance naïve or treated with another biosimilar at baseline.
for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease).
participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

Who cannot join

Participant treated for psoriasis.
Participant who are not to be followed up in the same investigator site for 2 years after baseline.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

France60 sites

Research Site
Amiens, Hauts-de-France
Research Site
Angers, Pays de la Loire Region
Research Site
Bayonne, New Aquitaine
Research Site 1
Bobigny, Île-de-France Region
Research Site
Bobigny, Île-de-France Region
Research Site
Bordeaux, New Aquitaine
Research Site 1
Brest, Brittany Region
Research Site
Brest, Brittany Region
Research Site
Caen, Normandy
Research Site
Caluire-et-Cuire, Auvergne-Rhône-Alpes
Research Site
Cannes, Provence-Alpes-Côte d'Azur Region
Research Site
Chambray-lès-Tours, Centre-Val de Loire
Research Site 1
Clermont-Ferrand, Auvergne-Rhône-Alpes
Research Site
Clermont-Ferrand, Auvergne-Rhône-Alpes
Research Site
Clichy, Île-de-France Region
Research Site
Colombes, Île-de-France Region
Research Site
Créteil, Île-de-France Region
Research Site
Dijon, Bourgogne-Franche-Comté
Research Site
La Crau, Provence-Alpes-Côte d'Azur Region
Research Site 1
La Rochelle, New Aquitaine
Research Site 2
La Rochelle, New Aquitaine
Research Site
La Rochelle, New Aquitaine
Research Site
Le Kremlin-Bicêtre, Île-de-France Region
Research Site 1
Lille, Hauts-de-France
Research Site
Lille, Hauts-de-France
Research Site
Limoges, New Aquitaine
Research Site
Lyon, Auvergne-Rhône-Alpes
Research Site 1
Marseille, Provence-Alpes-Côte d'Azur Region
Research Site
Marseille, Provence-Alpes-Côte d'Azur Region
Research Site 1
Montpellier, Occitanie
Research Site
Montpellier, Occitanie
Research Site 1
Nantes, Pays de la Loire Region
Research Site
Nantes, Pays de la Loire Region
Research Site
Nice, Provence-Alpes-Côte d'Azur Region
Research Site 1
Nîmes, Occitanie
Research Site
Nîmes, Occitanie
Research Site
Orléans, Centre-Val de Loire
Research Site 10
Paris, Île-de-France Region
Research Site 1
Paris, Île-de-France Region
Research Site 2
Paris, Île-de-France Region
Research Site 3
Paris, Île-de-France Region
Research Site 4
Paris, Île-de-France Region
Research Site 5
Paris, Île-de-France Region
Research Site 6
Paris, Île-de-France Region
Research Site 7
Paris, Île-de-France Region
Research Site 8
Paris, Île-de-France Region
Research Site 9
Paris, Île-de-France Region
Research Site
Paris, Île-de-France Region
Research Site 1
Pierre-Bénite, Auvergne-Rhône-Alpes
Research Site
Pierre-Bénite, Auvergne-Rhône-Alpes
Research Site
Reims, Grand Est
Research Site
Rennes, Brittany Region
Research Site
Rouen, Normandy
Research Site
Saint-Etienne, Auvergne-Rhône-Alpes
Research Site
Strasbourg, Grand Est
Research Site
Toulon, Provence-Alpes-Côte d'Azur Region
Research Site 1
Toulouse, Occitanie
Research Site
Toulouse, Occitanie
Research Site 1
Vandœuvre-lès-Nancy, Grand Est
Research Site
Vandœuvre-lès-Nancy, Grand Est

Other trials in France

About this study

Official title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

Conditions: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn's Disease, Colitis, Ulcerative
Being tested: Infliximab, Adalimumab
Medical subject headings: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InfliximabDrug
Also called Flixabi
Administered as specified in the treatment arm.
AdalimumabDrug
Also called Imraldi
Administered as specified in the treatment arm.

Study groups in NCT03662919
Study group	Role	What they receive
Flixabi		Infliximab naive participants or participants who were previously treated with other infliximab biologics will receive Flixabi (infliximab) as prescribed by physician according to the local prescribing procedures. Receives: Drug: Infliximab
Imraldi		Adalimumab naive participants or participants who were previously treated with other adalimumab biosimilars will receive Imraldi (adalimumab) as prescribed by physician according to the local prescribing procedures. Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201830 Jun 2022

First posted10 Sep 2018
Study start2 Jul 2018
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by BiogenThe 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: Prospective
Enrolment: 2,274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03662919
Sponsor's protocol ID: FRA-FLX-17-11226
Other IDs: 2017-A03220-53
Acronym: PERFUSE
Status last verified: Oct 2022
First submitted: 6 Sep 2018
Last updated: 18 Oct 2022
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, Maugars Y, Flamant M, Coury F, Braithwaite B, Hateb S, Addison J; PERFUSE investigators. Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study. Drugs Real World Outcomes. 2024 Dec;11(4):573-591. doi: 10.1007/s40801-024-00459-6. Epub 2024 Oct 10.
PubMed 39384685
Fautrel B, Bouhnik Y, Dieude P, Richette P, Dougados M, Freudensprung U, Brigui A, Addison J. Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study. Rheumatol Adv Pract. 2023 Apr 17;7(2):rkad031. doi: 10.1093/rap/rkad031. eCollection 2023.
PubMed 37122809
Martinez-Vinson C, Lemoine A, Bouhnik Y, Braithwaite B, Fohlen-Weill A, Addison J. PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2023 Apr 1;76(4):451-459. doi: 10.1097/MPG.0000000000003683. Epub 2022 Dec 16.
PubMed 36729422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
ClinicalTrials.gov ID: NCT03662919
Acronym / sponsor ID: PERFUSE / FRA-FLX-17-11226
Conditions: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn's Disease, Colitis, Ulcerative
Study type: Observational
Recruitment status: Completed
Enrolment: 2,274 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: 2 Jul 2018 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 10 Sep 2018 (actual)
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Flixabi	–	Drug: InfliximabInfliximab naive participants or participants who were previously treated with other infliximab biologics will receive Flixabi (infliximab) as prescribed by physician according to the local prescribing procedures.
Imraldi	–	Drug: AdalimumabAdalimumab naive participants or participants who were previously treated with other adalimumab biosimilars will receive Imraldi (adalimumab) as prescribed by physician according to the local prescribing procedures.

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants either infliximab naïve or switched from Remicade or CT-P13 to Flixabi who are treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi who are treated with Imraldi, for RA, AS, PsA, CD, and UC as prescribed by the physician in clinical practice.

Key inclusion criteria (10 listed)

Adult participant (18 years and over)
Paediatric participants (6-17 years):

Key exclusion criteria (3 listed)

Participant treated for psoriasis.
Participant who are not to be followed up in the same investigator site for 2 years after baseline.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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
InfliximabAlso: FlixabiAdministered as specified in the treatment arm.	Drug	Flixabi
AdalimumabAlso: ImraldiAdministered as specified in the treatment arm.	Drug	Imraldi

Primary outcome

Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
Time frame: Up to 12 months
Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.

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 18 Oct 2022.
Derived from this study: PubMed 39384685Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, Maugars Y, Flamant M, Coury F, Braithwaite B, Hateb S, Addison J; PERFUSE investigators. Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study. Drugs Real World Outcomes. 2024 Dec;11(4):573-591. doi: 10.1007/s40801-024-00459-6. Epub 2024 Oct 10.
Derived from this study: PubMed 37122809Fautrel B, Bouhnik Y, Dieude P, Richette P, Dougados M, Freudensprung U, Brigui A, Addison J. Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study. Rheumatol Adv Pract. 2023 Apr 17;7(2):rkad031. doi: 10.1093/rap/rkad031. eCollection 2023.
Derived from this study: PubMed 36729422Martinez-Vinson C, Lemoine A, Bouhnik Y, Braithwaite B, Fohlen-Weill A, Addison J. PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2023 Apr 1;76(4):451-459. doi: 10.1097/MPG.0000000000003683. Epub 2022 Dec 16.

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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.

Medical Director study director

Biogen

60 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by Biogen at 60 sites 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 10 inclusion and 3 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites 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 Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months (time frame: Up to 12 months). 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 NCT03662919, which also lists 3 linked publications.

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 18 Oct 2022.