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

Last updated: June 10, 2024
Sponsor: Fresenius Kabi, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psoriatic Arthritis

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT05598684
2022-A00946-37
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 18 years or over

  • Patient who have been informed of the objectives and the conditions of the study andwho did not object to its participation

  • Patient diagnosed with one chronic inflammatory rheumatological (rheumatoidarthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatorybowel (Crohn's disease, ulcerative colitis) diseases

  • Patient for whom the investigator has decided, with patient's agreement and prior toinclusion:

  • Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)

  • Either to replace Humira® with a biosimilar (AdalimumabFK)

Exclusion

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 (patientnot contactable by telephone, unable to complete the self-administeredquestionnaire, or having poor French language skills, etc.)

Study Design

Total Participants: 600
Study Start date:
November 24, 2022
Estimated Completion Date:
December 30, 2025

Study 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

Connect with a study center

  • Nouvelle Clinique BONNEFON

    Alès, 30100
    France

    Site Not Available

  • Ch Amiens Nord

    Amiens, 80054
    France

    Active - Recruiting

  • Chu Amiens Picardie Site Sud

    Amiens, 80054
    France

    Active - Recruiting

  • Cabinet Médical

    Argelès-sur-Mer, 66700
    France

    Site Not Available

  • Ch Armentieres

    Armentières, 59280
    France

    Site Not Available

  • CH d'ARDECHE MERDIONALE

    Aubenas, 07200
    France

    Site Not Available

  • Cabinet de Gastroentérologie

    Bayonne, 64100aa
    France

    Active - Recruiting

  • Cabinet Médical

    Besançon, 25000
    France

    Site Not Available

  • Chu Besancon Hopital Jean Minjoz

    Besançon, 25000
    France

    Active - Recruiting

  • Clinique du Cèdre

    Bois-Guillaume, 76230
    France

    Site Not Available

  • AP HP Ambroise PARE

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Ch Boulogne Sur Mer

    Boulogne-sur-Mer, 62321
    France

    Site Not Available

  • Hôpital Privé SAINT-MARTIN

    Caen, 14050
    France

    Active - Recruiting

  • Centre Consultations Polyclinique St Jean

    Cagnes-sur-Mer, 06800
    France

    Active - Recruiting

  • Ch Cahors

    Cahors, 46000
    France

    Active - Recruiting

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69641
    France

    Active - Recruiting

  • Clinique du Parc

    Castelnau-le-Lez, 34170
    France

    Active - Recruiting

  • Cabinet Médical

    Chilly-Mazarin, 91380
    France

    Site Not Available

  • Ch Chateauroux

    Châteauroux, 36019
    France

    Active - Recruiting

  • CHU CLERMONT FERRAND, site ESTAING

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Chu Gabriell Monpied

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • AP HP Hôpital BEAUJON

    Clichy, 92110
    France

    Active - Recruiting

  • Ch Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Active - Recruiting

  • Clinique Claude BERNARD

    Ermont, 95120
    France

    Site Not Available

  • Centre Gastro Loire

    Gien, 45500
    France

    Site Not Available

  • Ch Haguenau

    Haguenau, 67504
    France

    Active - Recruiting

  • Cabinet Médical

    La Madeleine, 59110
    France

    Site Not Available

  • Forum Médica

    Lattes, 34970
    France

    Active - Recruiting

  • Ch Chartres Louis Pasteur

    Le Coudray, 28630
    France

    Active - Recruiting

  • Cabinet Médical Groupe

    Le Folgoët, 29260
    France

    Site Not Available

  • AP HP Hôpital BICETRE

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Cabinet Médical de Rhumatologie

    Lezignan Corbieres, 11200
    France

    Site Not Available

  • Chu Dupuytren 2

    Limoges, 87042
    France

    Active - Recruiting

  • Ch Bretagne Sud

    Lorient, 56322
    France

    Active - Recruiting

  • Medipole de La Meurthe - Cabinet Médical

    Lunéville, 54300
    France

    Site Not Available

  • Cabinet Médical TILSITT

    Lyon, 69002
    France

    Active - Recruiting

  • Hopital Prive Jean Mermoz Cabinet Medica

    Lyon, 69008
    France

    Active - Recruiting

  • Maison Médicale

    Marolles-en-Brie, 94440
    France

    Active - Recruiting

  • AP HM Hôpital NORD

    Marseille, 13015
    France

    Active - Recruiting

  • Centre Mutualiste LA FEUILLERAIE

    Marseille, 13004
    France

    Site Not Available

  • Cabinet de Rhumatologie

    Mennecy, 91540
    France

    Active - Recruiting

  • Ch Montauban

    Montauban, 82000
    France

    Site Not Available

  • Clinique PONT DE CHAUME

    Montauban, 82000
    France

    Active - Recruiting

  • MIMOUNE

    Montereau-fault-yonne, 77130
    France

    Active - Recruiting

  • Ghi Le Raincy Montfermeil

    Montfermeil, 93370
    France

    Active - Recruiting

  • Chu Hôtel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Institut Des Mici-Clinique Ambroise Paré

    Neuilly-sur-Seine, 92 200
    France

    Active - Recruiting

  • Cabinet Médical

    Nice, 06000
    France

    Active - Recruiting

  • Chu Nice Hôpital Pasteur

    Nice, 06000
    France

    Active - Recruiting

  • AP HP Hôpital LARRIBOISIERE

    Paris, 75010
    France

    Active - Recruiting

  • AP HP Hôpital SAINT ANTOINE

    Paris, 75012
    France

    Site Not Available

  • Ap Hp Gh Pitie Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • Cabinet Médical

    Paris, 75012
    France

    Site Not Available

  • Chu Bichat

    Paris, 75018
    France

    Active - Recruiting

  • Chu Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Ch Lyon Sud

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Cabinet Médical

    Poissy, 78300
    France

    Site Not Available

  • Cabinet Médical

    Poitiers, 86000
    France

    Active - Recruiting

  • Clinique CROIX du SUD

    Quint-Fonsegrives, 31130
    France

    Site Not Available

  • Hôpital Robert DEBRE

    Reims, 51092
    France

    Active - Recruiting

  • Chu Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • Cabinet Médical

    Rodez, 12000
    France

    Active - Recruiting

  • Cabinet Médical

    Saint-Amand-les-Eaux, 59230
    France

    Active - Recruiting

  • Hôpital St-Avold Groupe Sos Santé

    Saint-Avold, 57500
    France

    Active - Recruiting

  • Cabinet Médical

    Saint-Louis, 68300
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées BEGIN

    Saint-Mandé, 94160
    France

    Active - Recruiting

  • Chu Saint Etienne Hôpital Nord

    Saint-Étienne, 42055
    France

    Active - Recruiting

  • Cabinet Médical

    Sarreguemines, 57200
    France

    Site Not Available

  • Cabinet Médical

    Strasbourg, 6700
    France

    Site Not Available

  • Ch Strasbourg Hôpital Hautepierre

    Strasbourg, 6700
    France

    Active - Recruiting

  • Nouvel Hôpital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • Ch Tarbes Lourdes

    Tarbes, 65013
    France

    Active - Recruiting

  • Hôpital Bel Air

    Thionville, 57126
    France

    Active - Recruiting

  • Cabinet Médical

    Toulon, 83000
    France

    Active - Recruiting

  • HIA Hôpital SAINT-ANNE

    Toulon, 83800
    France

    Active - Recruiting

  • CHU PURPAN Hôpital PIERRE PAUL RIQUET

    Toulouse, 31059
    France

    Active - Recruiting

  • Chu Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Clinique MEDIPOLE GARONNE

    Toulouse, 31100
    France

    Active - Recruiting

  • Clinique PASTEUR

    Toulouse, 31300
    France

    Active - Recruiting

  • Clinique PASTEUR

    Toulouse Cedex, 31076
    France

    Active - Recruiting

  • Cabinet Médical

    Tourcoing, 59200
    France

    Site Not Available

  • Centre Rééd. Fonct. Trestel - Ch Lannion

    Trévou-Tréguignec, 22660
    France

    Active - Recruiting

  • Hpda Site Clinique Générale

    Valence, 26000
    France

    Active - Recruiting

  • Cabinet de Rhumatologie

    Valenciennes, 59300
    France

    Active - Recruiting

  • Cabinet Médical

    Vannes, 56000
    France

    Active - Recruiting

  • Ch Villeneuve Pôle de Sante Villeneuvois

    Villeneuve-sur-Lot, 47305
    France

    Active - Recruiting

  • Cabinet Médical

    Villeurbanne, 69100
    France

    Active - Recruiting

  • Ghm Les Portes Du Sud

    Vénissieux, 69200
    France

    Active - Recruiting

  • Chu Grenoble Sud

    Échirolles, 38130
    France

    Active - Recruiting

  • Ch Annecy Genevois

    Épagny, 74370
    France

    Active - Recruiting

  • Cabinet Médical

    Pointe à Pitre, 97110
    Guadeloupe

    Active - Recruiting

  • Cabinet Médical

    Saint Pierre, 97410
    Martinique

    Active - Recruiting

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