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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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
  • Nouvelle Clinique BONNEFON

    Alès, 30100

    Christos GEROS, MD

    Not yet recruiting
  • Ch Amiens Nord

    Amiens, 80054

    Vincent GOEB, MD

    Recruiting
  • Chu Amiens Picardie Site Sud

    Amiens, 80054

    Mathurin FUMERY, MD

    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

    Not yet recruiting
  • Cabinet de Gastroentérologie

    Bayonne, 64100aa

    Alexandre GIRAUD, MD

    Recruiting
  • Cabinet Médical

    Besançon, 25000

    Françoise CHAPAS JOLIVET, MD

    Not yet recruiting
  • Chu Besancon Hopital Jean Minjoz

    Besançon, 25000

    Stéphane KOCH, MD

    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

    Not yet 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

    Recruiting
  • Cabinet Médical

    Chilly-Mazarin, 91380

    Mouloud OUAFI, MD

    Not yet 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

    Recruiting
  • Clinique Claude BERNARD

    Ermont, 95120

    Benoit BORDACHAR, MD

    Not yet recruiting
  • Centre Gastro Loire

    Gien, 45500

    David FALLIK, MD

    Not yet recruiting
  • Ch Haguenau

    Haguenau, 67504

    Yves ARONDEL, MD

    Recruiting
  • Cabinet Médical

    La Madeleine, 59110

    Gauthier MOREL, MD

    Not yet recruiting
  • Forum Médica

    Lattes, 34970

    Thierry OUALID, MD

    Recruiting
  • Ch Chartres Louis Pasteur

    Le Coudray, 28630

    Valérie ROYANT, MD

    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

    Not yet recruiting
  • Chu Dupuytren 2

    Limoges, 87042

    Pascale VERGNE SALLE, MD

    Recruiting
  • Ch Bretagne Sud

    Lorient, 56322

    Pauline MARTEAU, MD

    Recruiting
  • Medipole de La Meurthe - Cabinet Médical

    Lunéville, 54300

    Franck LENTINI, MD

    Not yet 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

    Recruiting
  • Centre Mutualiste LA FEUILLERAIE

    Marseille, 13004

    Nassim GUERROUI, MD

    Not yet recruiting
  • AP HM Hôpital NORD

    Marseille, 13015

    Mélanie SERRERO, MD

    Recruiting
  • Cabinet de Rhumatologie

    Mennecy, 91540

    Christophe THEPOT, MD

    Recruiting
  • Ch Montauban

    Montauban, 82000

    Eve DAVID VAUDEY, MD

    Not yet 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

    Recruiting
  • AP HP Hôpital SAINT ANTOINE

    Paris, 75012

    Arsène MEKINIAN, MD

    Not yet recruiting
  • Cabinet Médical

    Paris, 75012

    Christian REVOL, MD

    Not yet 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

    Recruiting
  • Cabinet Médical

    Poissy, 78300

    Serge RAMBAUD, MD

    Not yet recruiting
  • Cabinet Médical

    Poitiers, 86000

    Gabriel MASSON, MD

    Recruiting
  • Clinique CROIX du SUD

    Quint-Fonsegrives, 31130

    Pierre TOULEMONDE, MD

    Not yet 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

    Recruiting
  • Cabinet Médical

    Sarreguemines, 57200

    Laurent DEFONTAINE, MD

    Not yet recruiting
  • Cabinet Médical

    Strasbourg, 6700

    Pierre LAZARUS, MD

    Recruiting
  • Cabinet Médical

    Strasbourg, 6700

    Philippe SCHNEIDER, MD

    Not yet 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

    Recruiting
  • Cabinet Médical

    Tourcoing, 59200

    Marine JARRY, MD

    Not yet 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

    Recruiting

Other trials in France

Guadeloupe1 site, 1 recruiting
  • Cabinet Médical

    Pointe-à-Pitre, 97110

    Rémi MISTRIH, MD

    Recruiting

Other trials in Guadeloupe

Martinique1 site, 1 recruiting
  • Cabinet Médical

    Saint-Pierre, 97410

    Judith PAYET DUBOURG, MD

    Recruiting

Other trials in Martinique

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
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 groups in NCT05598684
Study groupRoleWhat they receive
CohortAdult 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.

  1. 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

  2. Discontinuation of the biosimilar

    Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab

    Measured: Month 12

Secondary outcomes (7)
  1. 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

  2. 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

  3. 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

  4. Treatment acceptance

    Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire

    Measured: Day 0

  5. Quality of life assessment

    Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale

    Measured: Month 12

  6. Emotional state

    Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.

    Measured: Month 12

  7. 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.

  1. First posted28 Oct 2022
  2. Study start24 Nov 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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)
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

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.

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