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 (SAPHIR)

June 10, 2024 updated by: Fresenius Kabi, France

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Alès, France, 30100
        • Not yet recruiting
        • Nouvelle Clinique BONNEFON
        • Contact:
          • Christos GEROS, MD
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens Picardie Site Sud
        • Contact:
          • Mathurin Fumery, MD
      • Amiens, France, 80054
        • Recruiting
        • Ch Amiens Nord
        • Contact:
          • Vincent GOEB, MD
      • Argelès-sur-Mer, France, 66700
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Azzedine ARIF, MD
      • Armentières, France, 59280
        • Not yet recruiting
        • Ch Armentieres
        • Contact:
          • Amine MOUAMNIA, MD
      • Aubenas, France, 07200
        • Not yet recruiting
        • CH d'ARDECHE MERDIONALE
        • Contact:
          • Ludovic BACCONNIER, MD
      • Bayonne, France, 64100aa
        • Recruiting
        • Cabinet de Gastroentérologie
        • Contact:
          • Alexandre GIRAUD, MD
      • Besançon, France, 25000
        • Recruiting
        • CHU Besançon Hopital Jean Minjoz
        • Contact:
          • Stéphane KOCH, MD
      • Besançon, France, 25000
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Françoise CHAPAS JOLIVET, MD
      • Bois-Guillaume, France, 76230
        • Not yet recruiting
        • Clinique du Cèdre
        • Contact:
          • Stéphane LECLEIRE, MD
      • Boulogne-Billancourt, France, 92100
        • Not yet recruiting
        • AP HP Ambroise PARE
        • Contact:
          • Arianne LEBOIME GRIGANT, MD
      • Boulogne-sur-Mer, France, 62321
        • Not yet recruiting
        • CH Boulogne sur mer
        • Contact:
          • Renaud DESBARBIEUX, MD
      • Caen, France, 14050
        • Recruiting
        • Hôpital privé Saint-Martin
        • Contact:
          • Youlia RATAJCZYK, MD
      • Cagnes-sur-Mer, France, 06800
        • Recruiting
        • Centre Consultations Polyclinique St Jean
        • Contact:
          • Jérôme FILIPPI, MD
      • Cahors, France, 46000
        • Recruiting
        • CH Cahors
        • Contact:
          • Slim LASSOUED, MD
      • Caluire-et-Cuire, France, 69641
        • Recruiting
        • Infirmerie Protestante de Lyon
        • Contact:
          • André BASCH, MD
      • Castelnau-le-Lez, France, 34170
        • Recruiting
        • Clinique du Parc
        • Contact:
          • Guillaume PINETON DE CHAMBRUN, MD
      • Chilly-Mazarin, France, 91380
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Mouloud OUAFI, MD
      • Châteauroux, France, 36019
        • Recruiting
        • Ch Chateauroux
        • Contact:
          • Ahmed BENMANSOUR, MD
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU CLERMONT FERRAND, site ESTAING
        • Contact:
          • Anthony Buisson, MD
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Chu Gabriell Monpied
        • Contact:
          • Anne TOURNADRE, MD
      • Clichy, France, 92110
        • Recruiting
        • AP HP Hôpital BEAUJON
        • Contact:
          • Francisca JOLY, MD
      • Corbeil-Essonnes, France, 91100
        • Recruiting
        • CH Sud Francilien
        • Contact:
          • Pascal HILLIQUIN, MD
      • Ermont, France, 95120
        • Not yet recruiting
        • Clinique Claude Bernard
        • Contact:
          • Benoit BORDACHAR, MD
      • Gien, France, 45500
        • Not yet recruiting
        • Centre Gastro Loire
        • Contact:
          • David FALLIK, MD
      • Haguenau, France, 67504
        • Recruiting
        • CH Haguenau
        • Contact:
          • Yves ARONDEL, MD
      • La Madeleine, France, 59110
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Gauthier MOREL, MD
      • Lattes, France, 34970
        • Recruiting
        • Forum Médica
        • Contact:
          • Thierry OUALID, MD
      • Le Coudray, France, 28630
        • Recruiting
        • Ch Chartres Louis Pasteur
        • Contact:
          • Valérie ROYANT, MD
      • Le Folgoët, France, 29260
        • Not yet recruiting
        • Cabinet Médical Groupe
        • Contact:
          • Véronique de SAINT PIERRE, MD
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • AP HP Hôpital BICETRE
        • Contact:
          • Stephan PAVY, MD
      • Lezignan Corbieres, France, 11200
        • Not yet recruiting
        • Cabinet Médical de Rhumatologie
        • Contact:
          • Philippe VIU, MD
      • Limoges, France, 87042
        • Recruiting
        • CHU Dupuytren 2
        • Contact:
          • Pascale VERGNE SALLE, MD
      • Lorient, France, 56322
        • Recruiting
        • CH Bretagne Sud
        • Contact:
          • Pauline MARTEAU, MD
      • Lunéville, France, 54300
        • Not yet recruiting
        • Medipole de La Meurthe - Cabinet Médical
        • Contact:
          • Franck LENTINI, MD
      • Lyon, France, 69002
        • Recruiting
        • Cabinet Médical Tilsitt
        • Contact:
          • Frédéric NECTOUX, MD
      • Lyon, France, 69008
        • Recruiting
        • Hopital Prive Jean Mermoz Cabinet Medica
        • Contact:
          • Jérôme DESRAME, MD
      • Marolles-en-Brie, France, 94440
        • Recruiting
        • Maison médicale
        • Contact:
          • Djamila CHAWQI MANKOUR, MD
      • Marseille, France, 13004
        • Not yet recruiting
        • Centre Mutualiste LA FEUILLERAIE
        • Contact:
          • Nassim GUERROUI, MD
      • Marseille, France, 13015
        • Recruiting
        • AP HM Hôpital NORD
        • Contact:
          • Mélanie SERRERO, MD
      • Mennecy, France, 91540
        • Recruiting
        • Cabinet de Rhumatologie
        • Contact:
          • Christophe THEPOT, MD
      • Montauban, France, 82000
        • Not yet recruiting
        • CH Montauban
        • Contact:
          • Eve DAVID VAUDEY, MD
      • Montauban, France, 82000
        • Recruiting
        • Clinique Pont de Chaume
        • Contact:
          • Pascal BERGAMASCO, MD
      • Montereau-fault-yonne, France, 77130
        • Recruiting
        • MIMOUNE
        • Contact:
          • HOCINE MIMOUNE, MD
      • Montfermeil, France, 93370
        • Recruiting
        • GHI Le Raincy Montfermeil
        • Contact:
          • Azzedine DELLAL, MD
      • Nantes, France, 44093
        • Recruiting
        • CHU Hôtel Dieu
        • Contact:
          • Benoît LE GOFF, MD
      • Neuilly-sur-Seine, France, 92 200
        • Recruiting
        • Institut Des Mici-Clinique Ambroise Paré
        • Contact:
          • Yoram BOUHNIK, MD
      • Nice, France, 06000
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Emilie ACQUACALDA, MD
      • Nice, France, 06000
        • Recruiting
        • CHU Nice Hôpital Pasteur
        • Contact:
          • Christian Roux, MD
      • Paris, France, 75014
        • Recruiting
        • CHU Cochin
        • Contact:
          • Jérôme AVOUAC, MD
      • Paris, France, 75010
        • Recruiting
        • AP HP Hôpital LARRIBOISIERE
        • Contact:
          • Hang Korng EA, MD
      • Paris, France, 75012
        • Not yet recruiting
        • AP HP Hôpital SAINT ANTOINE
        • Contact:
          • Arsene Mekinian, MD
      • Paris, France, 75012
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Christian REVOL, MD
      • Paris, France, 75013
        • Recruiting
        • Ap Hp Gh Pitie Salpetriere
        • Contact:
          • Bruno FAUTREL, MD
      • Paris, France, 75013
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Valérie BERTON, MD
      • Paris, France, 75018
        • Recruiting
        • CHU Bichat
        • Contact:
          • Hakim BECHEUR, MD
      • Pierre-Bénite, France, 69495
        • Recruiting
        • CH Lyon Sud
        • Contact:
          • Cyrille CONFAVREUX, MD
      • Poissy, France, 78300
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Serge RAMBAUD, MD
      • Poitiers, France, 86000
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Gabriel MASSON, MD
      • Quint-Fonsegrives, France, 31130
        • Not yet recruiting
        • Clinique CROIX du SUD
        • Contact:
          • Pierre TOULEMONDE, MD
      • Reims, France, 51092
        • Recruiting
        • Hopital Robert Debre
        • Contact:
          • Guillaume Cadiot, MD
      • Rennes, France, 35033
        • Recruiting
        • CHU Pontchaillou
        • Contact:
          • Guillaume Bouguen, MD
      • Rodez, France, 12000
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Alain SIRVEN, MD
      • Saint-Amand-les-Eaux, France, 59230
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Medina BOUALIT, MD
      • Saint-Avold, France, 57500
        • Recruiting
        • Hôpital St-Avold Groupe Sos Santé
        • Contact:
          • Jean-Pierre CRUMBACH, MD
      • Saint-Louis, France, 68300
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Daniel BATTISTELLI, MD
      • Saint-Mandé, France, 94160
        • Recruiting
        • Hopital d'Instruction des Armees BEGIN
        • Contact:
          • Lisa BIALE, MD
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU Saint Etienne Hopital Nord
        • Contact:
          • Thierry THOMAS, MD
      • Sarreguemines, France, 57200
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Ali ABBAS, MD
      • Sarreguemines, France, 57200
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Laurent DEFONTAINE, MD
      • Strasbourg, France, 67091
        • Recruiting
        • Nouvel Hopital Civil
        • Contact:
          • Thierry MARTIN, MD
      • Strasbourg, France, 6700
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Pierre LAZARUS, MD
      • Strasbourg, France, 6700
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Philippe SCHNEIDER, MD
      • Strasbourg, France, 6700
        • Recruiting
        • Ch Strasbourg Hôpital Hautepierre
        • Contact:
          • Jean SIBILIA, MD
      • Tarbes, France, 65013
        • Recruiting
        • CH Tarbes Lourdes
        • Contact:
          • Guillaume LAUSTRIAT, MD
      • Thionville, France, 57126
        • Recruiting
        • Hôpital Bel Air
        • Contact:
          • Gael CINQUETTI, MD
      • Toulon, France, 83000
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Thierry CONSTANT, MD
      • Toulon, France, 83800
        • Recruiting
        • HIA Hôpital SAINT-ANNE
        • Contact:
          • Audrey CAMBON, MD
      • Toulouse, France, 31059
        • Recruiting
        • CHU Rangueil
        • Contact:
          • Cyrielle Gilletta de Saint Joseph, MD
      • Toulouse, France, 31300
        • Recruiting
        • Clinique Pasteur
        • Contact:
          • Mathieu GUIVARCH, MD
      • Toulouse, France, 31059
        • Recruiting
        • CHU Purpan Hôpital Pierre Paul Riquet
        • Contact:
          • Arnaud CONSTANTIN, MD
      • Toulouse, France, 31100
        • Recruiting
        • Clinique MEDIPOLE GARONNE
        • Contact:
          • Jean Frédéric BOYER, MD
      • Toulouse Cedex, France, 31076
        • Recruiting
        • Clinique Pasteur
        • Contact:
          • Patrick FAURE, MD
      • Tourcoing, France, 59200
        • Not yet recruiting
        • Cabinet Medical
        • Contact:
          • Marine JARRY, MD
      • Trévou-Tréguignec, France, 22660
        • Recruiting
        • Centre Rééd. Fonct. Trestel - Ch Lannion
        • Contact:
          • Dominique BARON, MD
      • Valence, France, 26000
        • Recruiting
        • Hpda Site Clinique Générale
        • Contact:
          • Damien CORBERAND, MD
      • Valenciennes, France, 59300
        • Recruiting
        • Cabinet de Rhumatologie
        • Contact:
          • Olivier DUNETON, MD
      • Vannes, France, 56000
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Laure LAMARE, MD
      • Villeneuve-sur-Lot, France, 47305
        • Recruiting
        • Ch Villeneuve Pôle de Sante Villeneuvois
        • Contact:
          • Pierre PAULY, MD
      • Villeurbanne, France, 69100
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Ahmed BENABDESSELAM, MD
      • Vénissieux, France, 69200
        • Recruiting
        • GHM les Portes du Sud
        • Contact:
          • Eric LEPRINCE, MD
      • Échirolles, France, 38130
        • Recruiting
        • CHU Grenoble Sud
        • Contact:
          • Athan BAILLET, MD
      • Épagny, France, 74370
        • Recruiting
        • CH Annecy Genevois
        • Contact:
          • Ewa BERTOLINI, MD
  • Guadeloupe
      • Pointe à Pitre, Guadeloupe, 97110
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Rémi MISTRIH, MD
  • Martinique
      • Saint Pierre, Martinique, 97410
        • Recruiting
        • Cabinet Medical
        • Contact:
          • Judith PAYET DUBOURG, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 12
Discontinuation of the biosimilar
Time Frame: Month 12
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical status
Time Frame: Day 0
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)
Day 0
Maintenance of therapeutic benefit
Time Frame: Month 6
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)
Month 6
Maintenance of therapeutic benefit
Time Frame: Month 12
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)
Month 12
Treatment acceptance
Time Frame: Day 0
Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire
Day 0
Quality of life assessment
Time Frame: Month 12
Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale
Month 12
Emotional state
Time Frame: Month 12
Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.
Month 12
Tolerability evaluation
Time Frame: Month 12
Collection of all adverse events (serious or non serious)
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00946-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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