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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Médical
        • 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 Médical
        • 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 Médical
        • 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 Médical
        • 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 Hotel 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 Médical
        • 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 Médical
        • Contact:
          • Christian REVOL, MD
      • Paris, France, 75013
        • Recruiting
        • Ap Hp Gh Pitie Salpetriere
        • Contact:
          • Bruno FAUTREL, MD
      • Paris, France, 75013
        • Recruiting
        • Cabinet Médical
        • 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 Médical
        • Contact:
          • Serge RAMBAUD, MD
      • Poitiers, France, 86000
        • Recruiting
        • Cabinet Médical
        • 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 Médical
        • Contact:
          • Alain SIRVEN, MD
      • Saint-Amand-les-Eaux, France, 59230
        • Recruiting
        • Cabinet Médical
        • 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 Médical
        • Contact:
          • Daniel BATTISTELLI, MD
      • Saint-Mandé, France, 94160
        • Recruiting
        • Hôpital d'Instruction des Armées Bégin
        • Contact:
          • Lisa BIALE, MD
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU Saint Etienne Hopital Nord
        • Contact:
          • Thierry THOMAS, MD
      • Sarreguemines, France, 57200
        • Recruiting
        • Cabinet Médical
        • Contact:
          • Ali ABBAS, MD
      • Sarreguemines, France, 57200
        • Not yet recruiting
        • Cabinet Médical
        • Contact:
          • Laurent DEFONTAINE, MD
      • Strasbourg, France, 67091
        • Recruiting
        • Nouvel hopital civil
        • Contact:
          • Thierry MARTIN, MD
      • Strasbourg, France, 6700
        • Recruiting
        • Cabinet Médical
        • Contact:
          • Pierre LAZARUS, MD
      • Strasbourg, France, 6700
        • Not yet recruiting
        • Cabinet Médical
        • 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 Médical
        • 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 Médipôle Garonne
        • Contact:
          • Jean Frédéric BOYER, MD
      • Toulouse Cedex, France, 31076
        • Recruiting
        • Clinique Pasteur
        • Contact:
          • Patrick FAURE, MD
      • Tourcoing, France, 59200
        • Not yet recruiting
        • Cabinet Médical
        • 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 Médical
        • 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 Médical
        • 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 Médical
        • Contact:
          • Rémi MISTRIH, MD
  • Martinique
      • Saint Pierre, Martinique, 97410
        • Recruiting
        • Cabinet Médical
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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