Crohn DiseaseSAPHIRNCT05598684
SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
An observational study of Crohn Disease and Ulcerative Colitis, run by Fresenius Kabi, France at 96 sites in 3 countries.
Trial summary
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis
- How many people
- 600 participants
- Where
- 96 sitesin 3 countries
- Study dates
- 24 Nov 2022to 30 Dec 2025
- 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: Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).
Who may be able to join
- Patient aged 18 years or over
- Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
- Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
- Patient for whom the investigator has decided, with patient's agreement and prior to inclusion:
- Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
- Either to replace Humira® with a biosimilar (AdalimumabFK)
Who cannot join
- Patient enrolled in an interventional therapeutic trial at the time of inclusion
- Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)
Trial locations and contacts
96 sites in 3 countries.
96 sites in 3 countries
France94 sites, 94 recruiting
- Not yet recruiting
Nouvelle Clinique BONNEFON
Alès, 30100
Christos GEROS, MD
- Recruiting
Ch Amiens Nord
Amiens, 80054
Vincent GOEB, MD
- Recruiting
Chu Amiens Picardie Site Sud
Amiens, 80054
Mathurin FUMERY, MD
- Not yet recruiting
Cabinet Médical
Argeles, 66700
Azzedine ARIF, MD
- Not yet recruiting
Ch Armentieres
Armentières, 59280
Amine MOUAMNIA, MD
- Not yet recruiting
CH d'ARDECHE MERDIONALE
Aubenas, 07200
Ludovic BACCONNIER, MD
- Recruiting
Cabinet de Gastroentérologie
Bayonne, 64100aa
Alexandre GIRAUD, MD
- Not yet recruiting
Cabinet Médical
Besançon, 25000
Françoise CHAPAS JOLIVET, MD
- Recruiting
Chu Besancon Hopital Jean Minjoz
Besançon, 25000
Stéphane KOCH, MD
- Not yet recruiting
Clinique du Cèdre
Bois-Guillaume, 76230
Stéphane LECLEIRE, MD
- Not yet recruiting
AP HP Ambroise PARE
Boulogne-Billancourt, 92100
Arianne LEBOIME GRIGANT, MD
- Not yet recruiting
Ch Boulogne Sur Mer
Boulogne-sur-Mer, 62321
Renaud DESBARBIEUX, MD
- Recruiting
Hôpital Privé SAINT-MARTIN
Caen, 14050
Youlia RATAJCZYK, MD
- Recruiting
Centre Consultations Polyclinique St Jean
Cagnes-sur-Mer, 06800
Jérôme FILIPPI, MD
- Recruiting
Ch Cahors
Cahors, 46000
Slim LASSOUED, MD
- Recruiting
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69641
André BASCH, MD
- Recruiting
Clinique du Parc
Castelnau-le-Lez, 34170
Guillaume PINETON DE CHAMBRUN, MD
- Recruiting
Ch Chateauroux
Châteauroux, 36019
Ahmed BENMANSOUR, MD
- Not yet recruiting
Cabinet Médical
Chilly-Mazarin, 91380
Mouloud OUAFI, MD
- Recruiting
CHU CLERMONT FERRAND, site ESTAING
Clermont-Ferrand, 63000
Anthony BUISSON, MD
- Recruiting
Chu Gabriell Monpied
Clermont-Ferrand, 63000
Anne TOURNADRE, MD
- Recruiting
AP HP Hôpital BEAUJON
Clichy, 92110
Francisca JOLY, MD
- Recruiting
Ch Sud Francilien
Corbeil-Essonnes, 91100
Pascal HILLIQUIN, MD
- Recruiting
Chu Grenoble Sud
Échirolles, 38130
Athan BAILLET, MD
- Recruiting
Ch Annecy Genevois
Épagny, 74370
Ewa BERTOLINI, MD
- Not yet recruiting
Clinique Claude BERNARD
Ermont, 95120
Benoit BORDACHAR, MD
- Not yet recruiting
Centre Gastro Loire
Gien, 45500
David FALLIK, MD
- Recruiting
Ch Haguenau
Haguenau, 67504
Yves ARONDEL, MD
- Not yet recruiting
Cabinet Médical
La Madeleine, 59110
Gauthier MOREL, MD
- Recruiting
Forum Médica
Lattes, 34970
Thierry OUALID, MD
- Recruiting
Ch Chartres Louis Pasteur
Le Coudray, 28630
Valérie ROYANT, MD
- Not yet recruiting
Cabinet Médical Groupe
Le Folgoët, 29260
Véronique de SAINT PIERRE, MD
- Not yet recruiting
AP HP Hôpital BICETRE
Le Kremlin-Bicêtre, 94270
Stephan PAVY, MD
- Not yet recruiting
Cabinet Médical de Rhumatologie
Lézignan-Corbières, 11200
Philippe VIU, MD
- Recruiting
Chu Dupuytren 2
Limoges, 87042
Pascale VERGNE SALLE, MD
- Recruiting
Ch Bretagne Sud
Lorient, 56322
Pauline MARTEAU, MD
- Not yet recruiting
Medipole de La Meurthe - Cabinet Médical
Lunéville, 54300
Franck LENTINI, MD
- Recruiting
Cabinet Médical TILSITT
Lyon, 69002
Frédéric NECTOUX, MD
- Recruiting
Hopital Prive Jean Mermoz Cabinet Medica
Lyon, 69008
Jérôme DESRAME, MD
- Recruiting
Maison Médicale
Marolles-en-Brie, 94440
Djamila CHAWQI MANKOUR, MD
- Not yet recruiting
Centre Mutualiste LA FEUILLERAIE
Marseille, 13004
Nassim GUERROUI, MD
- Recruiting
AP HM Hôpital NORD
Marseille, 13015
Mélanie SERRERO, MD
- Recruiting
Cabinet de Rhumatologie
Mennecy, 91540
Christophe THEPOT, MD
- Not yet recruiting
Ch Montauban
Montauban, 82000
Eve DAVID VAUDEY, MD
- Recruiting
Clinique PONT DE CHAUME
Montauban, 82000
Pascal BERGAMASCO, MD
- Recruiting
MIMOUNE
Montereau-Fault-Yonne, 77130
HOCINE MIMOUNE, MD
- Recruiting
Ghi Le Raincy Montfermeil
Montfermeil, 93370
Azzedine DELLAL, MD
- Recruiting
Chu Hôtel Dieu
Nantes, 44093
Benoît LE GOFF, MD
- Recruiting
Institut Des Mici-Clinique Ambroise Paré
Neuilly-sur-Seine, 92 200
Yoram BOUHNIK, MD
- Recruiting
Cabinet Médical
Nice, 06000
Emilie ACQUACALDA, MD
- Recruiting
Chu Nice Hôpital Pasteur
Nice, 06000
Christian ROUX, MD
- Recruiting
AP HP Hôpital LARRIBOISIERE
Paris, 75010
Hang Korng EA, MD
- Not yet recruiting
AP HP Hôpital SAINT ANTOINE
Paris, 75012
Arsène MEKINIAN, MD
- Not yet recruiting
Cabinet Médical
Paris, 75012
Christian REVOL, MD
- Recruiting
Ap Hp Gh Pitie Salpetriere
Paris, 75013
Bruno FAUTREL, MD
- Recruiting
Cabinet Médical
Paris, 75013
Valérie BERTON, MD
- Recruiting
Chu Cochin
Paris, 75014
Jérôme AVOUAC, MD
- Recruiting
Chu Bichat
Paris, 75018
Hakim BECHEUR, MD
- Recruiting
Ch Lyon Sud
Pierre-Bénite, 69495
Cyrille CONFAVREUX, MD
- Not yet recruiting
Cabinet Médical
Poissy, 78300
Serge RAMBAUD, MD
- Recruiting
Cabinet Médical
Poitiers, 86000
Gabriel MASSON, MD
- Not yet recruiting
Clinique CROIX du SUD
Quint-Fonsegrives, 31130
Pierre TOULEMONDE, MD
- Recruiting
Hôpital Robert DEBRE
Reims, 51092
Guillaume CADIOT, MD
- Recruiting
Chu Pontchaillou
Rennes, 35033
Guillaume BOUGUEN, MD
- Recruiting
Cabinet Médical
Rodez, 12000
Alain SIRVEN, MD
- Recruiting
Cabinet Médical
Saint-Amand-les-Eaux, 59230
Medina BOUALIT, MD
- Recruiting
Hôpital St-Avold Groupe Sos Santé
Saint-Avold, 57500
Jean-Pierre CRUMBACH, MD
- Recruiting
Chu Saint Etienne Hôpital Nord
Saint-Etienne, 42055
Thierry THOMAS, MD
- Recruiting
Cabinet Médical
Saint-Louis, 68300
Daniel BATTISTELLI, MD
- Recruiting
Hôpital d'Instruction des Armées BEGIN
Saint-Mandé, 94160
Lisa BIALE, MD
- Recruiting
Cabinet Médical
Sarreguemines, 57200
Ali ABBAS, MD
- Not yet recruiting
Cabinet Médical
Sarreguemines, 57200
Laurent DEFONTAINE, MD
- Recruiting
Cabinet Médical
Strasbourg, 6700
Pierre LAZARUS, MD
- Not yet recruiting
Cabinet Médical
Strasbourg, 6700
Philippe SCHNEIDER, MD
- Recruiting
Ch Strasbourg Hôpital Hautepierre
Strasbourg, 6700
Jean SIBILIA, MD
- Recruiting
Nouvel Hôpital Civil
Strasbourg, 67091
Thierry MARTIN, MD
- Recruiting
Ch Tarbes Lourdes
Tarbes, 65013
Guillaume LAUSTRIAT, MD
- Recruiting
Hôpital Bel Air
Thionville, 57126
Gael CINQUETTI, MD
- Recruiting
Cabinet Médical
Toulon, 83000
Thierry CONSTANT, MD
- Recruiting
HIA Hôpital SAINT-ANNE
Toulon, 83800
Audrey CAMBON, MD
- Recruiting
CHU PURPAN Hôpital PIERRE PAUL RIQUET
Toulouse, 31059
Arnaud CONSTANTIN, MD
- Recruiting
Chu Rangueil
Toulouse, 31059
Cyrielle GILLETTA de SAINT JOSEPH, MD
- Recruiting
Clinique PASTEUR
Toulouse, 31076
Patrick FAURE, MD
- Recruiting
Clinique MEDIPOLE GARONNE
Toulouse, 31100
Jean Frédéric BOYER, MD
- Recruiting
Clinique PASTEUR
Toulouse, 31300
Mathieu GUIVARCH, MD
- Not yet recruiting
Cabinet Médical
Tourcoing, 59200
Marine JARRY, MD
- Recruiting
Centre Rééd. Fonct. Trestel - Ch Lannion
Trévou-Tréguignec, 22660
Dominique BARON, MD
- Recruiting
Hpda Site Clinique Générale
Valence, 26000
Damien CORBERAND, MD
- Recruiting
Cabinet de Rhumatologie
Valenciennes, 59300
Olivier DUNETON, MD
- Recruiting
Cabinet Médical
Vannes, 56000
Anne-Hélène DELALANDE, MD
- Recruiting
Cabinet Médical
Vannes, 56000
Laure LAMARE, MD
- Recruiting
Ghm Les Portes Du Sud
Vénissieux, 69200
Eric LEPRINCE, MD
- Recruiting
Ch Villeneuve Pôle de Sante Villeneuvois
Villeneuve-sur-Lot, 47305
Pierre PAULY, MD
- Recruiting
Cabinet Médical
Villeurbanne, 69100
Ahmed BENABDESSELAM, MD
Guadeloupe1 site, 1 recruiting
- Recruiting
Cabinet Médical
Pointe-à-Pitre, 97110
Rémi MISTRIH, MD
Martinique1 site, 1 recruiting
- Recruiting
Cabinet Médical
Saint-Pierre, 97410
Judith PAYET DUBOURG, MD
About this study
Official title: Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Read the detailed description
In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
- Primary objective: to define predictive factors for the persistence of treatment
- Secondary objectives:
- To assess the therapeutic benefit and the tolerability of the treatment
- To describe the reasons for treatment discontinuations occurring during follow-up
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of the biosimilar
Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period
Measured: Month 12
Discontinuation of the biosimilar
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Measured: Month 12
Secondary outcomes (7)
Clinical status
Clinical Global Impression (CGI)-severity scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
Measured: Day 0
Maintenance of therapeutic benefit
Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
Measured: Month 6
Maintenance of therapeutic benefit
Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
Measured: Month 12
Treatment acceptance
Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire
Measured: Day 0
Quality of life assessment
Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale
Measured: Month 12
Emotional state
Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.
Measured: Month 12
Tolerability evaluation
Collection of all adverse events (serious or non serious)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start24 Nov 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598684
- Sponsor's protocol ID
- 2022-A00946-37
- Acronym
- SAPHIR
- Status last verified
- Jul 2023
- First submitted
- 25 Oct 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT05598684
- Acronym / sponsor ID
- SAPHIR / 2022-A00946-37
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fresenius Kabi, FranceIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Oct 2022 (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.
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Detailed description
In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
- Primary objective: to define predictive factors for the persistence of treatment
- Secondary objectives:
- To assess the therapeutic benefit and the tolerability of the treatment
- To describe the reasons for treatment discontinuations occurring during follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).
Key inclusion criteria (6 listed)
- Patient aged 18 years or over
- Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
- Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
- Patient for whom the investigator has decided, with patient's agreement and prior to inclusion:
- Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
Key exclusion criteria (2 listed)
- Patient enrolled in an interventional therapeutic trial at the time of inclusion
- Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence of the biosimilar
Time frame: Month 12
Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period
Discontinuation of the biosimilar
Time frame: Month 12
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
7 secondary outcomes
Clinical status
Time frame: Day 0
Maintenance of therapeutic benefit
Time frame: Month 6
Maintenance of therapeutic benefit
Time frame: Month 12
Treatment acceptance
Time frame: Day 0
Quality of life assessment
Time frame: Month 12
Emotional state
Time frame: Month 12
Tolerability evaluation
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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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.
96 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by Fresenius Kabi, France at 96 sites in 3 countries.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in France, Guadeloupe, Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carole ROSATI (06 26 42 70 58 ext. 33, carole.rosati@fresenius-kabi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of the biosimilar (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2024.