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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

NCT ID: NCT05598684

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-24

Study Completion Date

2025-12-30

Brief Summary

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A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.

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Detailed Description

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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

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Crohn Disease Ulcerative Colitis Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi, France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nouvelle Clinique BONNEFON

Alès, , France

Site Status NOT_YET_RECRUITING

Ch Amiens Nord

Amiens, , France

Site Status RECRUITING

Chu Amiens Picardie Site Sud

Amiens, , France

Site Status RECRUITING

Cabinet Médical

Argeles, , France

Site Status NOT_YET_RECRUITING

Ch Armentieres

Armentières, , France

Site Status NOT_YET_RECRUITING

CH d'ARDECHE MERDIONALE

Aubenas, , France

Site Status NOT_YET_RECRUITING

Cabinet de Gastroentérologie

Bayonne, , France

Site Status RECRUITING

Cabinet Médical

Besançon, , France

Site Status NOT_YET_RECRUITING

Chu Besancon Hopital Jean Minjoz

Besançon, , France

Site Status RECRUITING

Clinique du Cèdre

Bois-Guillaume, , France

Site Status NOT_YET_RECRUITING

AP HP Ambroise PARE

Boulogne-Billancourt, , France

Site Status NOT_YET_RECRUITING

Ch Boulogne Sur Mer

Boulogne-sur-Mer, , France

Site Status NOT_YET_RECRUITING

Hôpital Privé SAINT-MARTIN

Caen, , France

Site Status RECRUITING

Centre Consultations Polyclinique St Jean

Cagnes-sur-Mer, , France

Site Status RECRUITING

Ch Cahors

Cahors, , France

Site Status RECRUITING

Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Site Status RECRUITING

Clinique du Parc

Castelnau-le-Lez, , France

Site Status RECRUITING

Ch Chateauroux

Châteauroux, , France

Site Status RECRUITING

Cabinet Médical

Chilly-Mazarin, , France

Site Status NOT_YET_RECRUITING

CHU CLERMONT FERRAND, site ESTAING

Clermont-Ferrand, , France

Site Status RECRUITING

Chu Gabriell Monpied

Clermont-Ferrand, , France

Site Status RECRUITING

AP HP Hôpital BEAUJON

Clichy, , France

Site Status RECRUITING

Ch Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

Clinique Claude BERNARD

Ermont, , France

Site Status NOT_YET_RECRUITING

Chu Grenoble Sud

Échirolles, , France

Site Status RECRUITING

Ch Annecy Genevois

Épagny, , France

Site Status RECRUITING

Centre Gastro Loire

Gien, , France

Site Status NOT_YET_RECRUITING

Ch Haguenau

Haguenau, , France

Site Status RECRUITING

Cabinet Médical

La Madeleine, , France

Site Status NOT_YET_RECRUITING

Forum Médica

Lattes, , France

Site Status RECRUITING

Ch Chartres Louis Pasteur

Le Coudray, , France

Site Status RECRUITING

Cabinet Médical Groupe

Le Folgoët, , France

Site Status NOT_YET_RECRUITING

AP HP Hôpital BICETRE

Le Kremlin-Bicêtre, , France

Site Status NOT_YET_RECRUITING

Cabinet Médical de Rhumatologie

Lézignan-Corbières, , France

Site Status NOT_YET_RECRUITING

Chu Dupuytren 2

Limoges, , France

Site Status RECRUITING

Ch Bretagne Sud

Lorient, , France

Site Status RECRUITING

Medipole de La Meurthe - Cabinet Médical

Lunéville, , France

Site Status NOT_YET_RECRUITING

Cabinet Médical TILSITT

Lyon, , France

Site Status RECRUITING

Hopital Prive Jean Mermoz Cabinet Medica

Lyon, , France

Site Status RECRUITING

Maison Médicale

Marolles-en-Brie, , France

Site Status RECRUITING

Centre Mutualiste LA FEUILLERAIE

Marseille, , France

Site Status NOT_YET_RECRUITING

AP HM Hôpital NORD

Marseille, , France

Site Status RECRUITING

Cabinet de Rhumatologie

Mennecy, , France

Site Status RECRUITING

Ch Montauban

Montauban, , France

Site Status NOT_YET_RECRUITING

Clinique PONT DE CHAUME

Montauban, , France

Site Status RECRUITING

MIMOUNE

Montereau-Fault-Yonne, , France

Site Status RECRUITING

Ghi Le Raincy Montfermeil

Montfermeil, , France

Site Status RECRUITING

Chu Hôtel Dieu

Nantes, , France

Site Status RECRUITING

Institut Des Mici-Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Site Status RECRUITING

Cabinet Médical

Nice, , France

Site Status RECRUITING

Chu Nice Hôpital Pasteur

Nice, , France

Site Status RECRUITING

AP HP Hôpital LARRIBOISIERE

Paris, , France

Site Status RECRUITING

AP HP Hôpital SAINT ANTOINE

Paris, , France

Site Status NOT_YET_RECRUITING

Cabinet Médical

Paris, , France

Site Status NOT_YET_RECRUITING

Ap Hp Gh Pitie Salpetriere

Paris, , France

Site Status RECRUITING

Cabinet Médical

Paris, , France

Site Status RECRUITING

Chu Cochin

Paris, , France

Site Status RECRUITING

Chu Bichat

Paris, , France

Site Status RECRUITING

Ch Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

Cabinet Médical

Poissy, , France

Site Status NOT_YET_RECRUITING

Cabinet Médical

Poitiers, , France

Site Status RECRUITING

Clinique CROIX du SUD

Quint-Fonsegrives, , France

Site Status NOT_YET_RECRUITING

Hôpital Robert DEBRE

Reims, , France

Site Status RECRUITING

Chu Pontchaillou

Rennes, , France

Site Status RECRUITING

Cabinet Médical

Rodez, , France

Site Status RECRUITING

Cabinet Médical

Saint-Amand-les-Eaux, , France

Site Status RECRUITING

Hôpital St-Avold Groupe Sos Santé

Saint-Avold, , France

Site Status RECRUITING

Chu Saint Etienne Hôpital Nord

Saint-Etienne, , France

Site Status RECRUITING

Cabinet Médical

Saint-Louis, , France

Site Status RECRUITING

Hôpital d'Instruction des Armées BEGIN

Saint-Mandé, , France

Site Status RECRUITING

Cabinet Médical

Sarreguemines, , France

Site Status RECRUITING

Cabinet Médical

Sarreguemines, , France

Site Status NOT_YET_RECRUITING

Cabinet Médical

Strasbourg, , France

Site Status RECRUITING

Cabinet Médical

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Ch Strasbourg Hôpital Hautepierre

Strasbourg, , France

Site Status RECRUITING

Nouvel Hôpital Civil

Strasbourg, , France

Site Status RECRUITING

Ch Tarbes Lourdes

Tarbes, , France

Site Status RECRUITING

Hôpital Bel Air

Thionville, , France

Site Status RECRUITING

Cabinet Médical

Toulon, , France

Site Status RECRUITING

HIA Hôpital SAINT-ANNE

Toulon, , France

Site Status RECRUITING

CHU PURPAN Hôpital PIERRE PAUL RIQUET

Toulouse, , France

Site Status RECRUITING

Chu Rangueil

Toulouse, , France

Site Status RECRUITING

Clinique PASTEUR

Toulouse, , France

Site Status RECRUITING

Clinique MEDIPOLE GARONNE

Toulouse, , France

Site Status RECRUITING

Clinique PASTEUR

Toulouse, , France

Site Status RECRUITING

Cabinet Médical

Tourcoing, , France

Site Status NOT_YET_RECRUITING

Centre Rééd. Fonct. Trestel - Ch Lannion

Trévou-Tréguignec, , France

Site Status RECRUITING

Hpda Site Clinique Générale

Valence, , France

Site Status RECRUITING

Cabinet de Rhumatologie

Valenciennes, , France

Site Status RECRUITING

Cabinet Médical

Vannes, , France

Site Status RECRUITING

Cabinet Médical

Vannes, , France

Site Status RECRUITING

Ghm Les Portes Du Sud

Vénissieux, , France

Site Status RECRUITING

Ch Villeneuve Pôle de Sante Villeneuvois

Villeneuve-sur-Lot, , France

Site Status RECRUITING

Cabinet Médical

Villeurbanne, , France

Site Status RECRUITING

Cabinet Médical

Pointe-à-Pitre, , Guadeloupe

Site Status RECRUITING

Cabinet Médical

Saint-Pierre, , Martinique

Site Status RECRUITING

Countries

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France Guadeloupe Martinique

Central Contacts

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Carole ROSATI

Role: CONTACT

[email protected]
06 26 42 70 58 ext. 33

Facility Contacts

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Christos GEROS, MD

Role: primary

Vincent GOEB, MD

Role: primary

Mathurin FUMERY, MD

Role: primary

Azzedine ARIF, MD

Role: primary

Amine MOUAMNIA, MD

Role: primary

Ludovic BACCONNIER, MD

Role: primary

Alexandre GIRAUD, MD

Role: primary

Françoise CHAPAS JOLIVET, MD

Role: primary

Stéphane KOCH, MD

Role: primary

Stéphane LECLEIRE, MD

Role: primary

Arianne LEBOIME GRIGANT, MD

Role: primary

Renaud DESBARBIEUX, MD

Role: primary

Youlia RATAJCZYK, MD

Role: primary

Jérôme FILIPPI, MD

Role: primary

Slim LASSOUED, MD

Role: primary

André BASCH, MD

Role: primary

Guillaume PINETON DE CHAMBRUN, MD

Role: primary

Ahmed BENMANSOUR, MD

Role: primary

Mouloud OUAFI, MD

Role: primary

Anthony BUISSON, MD

Role: primary

Anne TOURNADRE, MD

Role: primary

Francisca JOLY, MD

Role: primary

Pascal HILLIQUIN, MD

Role: primary

Benoit BORDACHAR, MD

Role: primary

Athan BAILLET, MD

Role: primary

Ewa BERTOLINI, MD

Role: primary

David FALLIK, MD

Role: primary

Yves ARONDEL, MD

Role: primary

Gauthier MOREL, MD

Role: primary

Thierry OUALID, MD

Role: primary

Valérie ROYANT, MD

Role: primary

Véronique de SAINT PIERRE, MD

Role: primary

Stephan PAVY, MD

Role: primary

Philippe VIU, MD

Role: primary

Pascale VERGNE SALLE, MD

Role: primary

Pauline MARTEAU, MD

Role: primary

Franck LENTINI, MD

Role: primary

Frédéric NECTOUX, MD

Role: primary

Jérôme DESRAME, MD

Role: primary

Djamila CHAWQI MANKOUR, MD

Role: primary

Nassim GUERROUI, MD

Role: primary

Mélanie SERRERO, MD

Role: primary

Christophe THEPOT, MD

Role: primary

Eve DAVID VAUDEY, MD

Role: primary

Pascal BERGAMASCO, MD

Role: primary

HOCINE MIMOUNE, MD

Role: primary

Azzedine DELLAL, MD

Role: primary

Benoît LE GOFF, MD

Role: primary

Yoram BOUHNIK, MD

Role: primary

Emilie ACQUACALDA, MD

Role: primary

Christian ROUX, MD

Role: primary

Hang Korng EA, MD

Role: primary

Arsène MEKINIAN, MD

Role: primary

Christian REVOL, MD

Role: primary

Bruno FAUTREL, MD

Role: primary

Valérie BERTON, MD

Role: primary

Jérôme AVOUAC, MD

Role: primary

Hakim BECHEUR, MD

Role: primary

Cyrille CONFAVREUX, MD

Role: primary

Serge RAMBAUD, MD

Role: primary

Gabriel MASSON, MD

Role: primary

Pierre TOULEMONDE, MD

Role: primary

Guillaume CADIOT, MD

Role: primary

Guillaume BOUGUEN, MD

Role: primary

Alain SIRVEN, MD

Role: primary

Medina BOUALIT, MD

Role: primary

Jean-Pierre CRUMBACH, MD

Role: primary

Thierry THOMAS, MD

Role: primary

Daniel BATTISTELLI, MD

Role: primary

Lisa BIALE, MD

Role: primary

Ali ABBAS, MD

Role: primary

Laurent DEFONTAINE, MD

Role: primary

Pierre LAZARUS, MD

Role: primary

Philippe SCHNEIDER, MD

Role: primary

Jean SIBILIA, MD

Role: primary

Thierry MARTIN, MD

Role: primary

Guillaume LAUSTRIAT, MD

Role: primary

Gael CINQUETTI, MD

Role: primary

Thierry CONSTANT, MD

Role: primary

Audrey CAMBON, MD

Role: primary

Arnaud CONSTANTIN, MD

Role: primary

Cyrielle GILLETTA de SAINT JOSEPH, MD

Role: primary

Patrick FAURE, MD

Role: primary

Jean Frédéric BOYER, MD

Role: primary

Mathieu GUIVARCH, MD

Role: primary

Marine JARRY, MD

Role: primary

Dominique BARON, MD

Role: primary

Damien CORBERAND, MD

Role: primary

Olivier DUNETON, MD

Role: primary

Anne-Hélène DELALANDE, MD

Role: primary

Laure LAMARE, MD

Role: primary

Eric LEPRINCE, MD

Role: primary

Pierre PAULY, MD

Role: primary

Ahmed BENABDESSELAM, MD

Role: primary

Rémi MISTRIH, MD

Role: primary

Judith PAYET DUBOURG, MD

Role: primary

Other Identifiers

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2022-A00946-37

Identifier Type: -

Identifier Source: org_study_id

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