Clinical trial NCT05598684: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Ulcerative Colitis
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: Fresenius Kabi, France
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).

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

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

Eligibility criteria: 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.)

Primary outcomes:
measure: Persistence of the biosimilar
timeFrame: Month 12
measure: Discontinuation of the biosimilar
timeFrame: Month 12
Secondary outcomes:
measure: Clinical status
timeFrame: Day 0
measure: Maintenance of therapeutic benefit
timeFrame: Month 6
measure: Maintenance of therapeutic benefit
timeFrame: Month 12
measure: Treatment acceptance
timeFrame: Day 0
measure: Quality of life assessment
timeFrame: Month 12
measure: Emotional state
timeFrame: Month 12
measure: Tolerability evaluation
timeFrame: Month 12
Other outcomes:
Locations:
city: Alès
country: France
facility: Nouvelle Clinique BONNEFON
city: Amiens
country: France
facility: Ch Amiens Nord
city: Amiens
country: France
facility: Chu Amiens Picardie Site Sud
city: Argelès-sur-Mer
country: France
facility: Cabinet Médical
city: Armentières
country: France
facility: Ch Armentieres
city: Aubenas
country: France
facility: CH d'ARDECHE MERDIONALE
city: Bayonne
country: France
facility: Cabinet de Gastroentérologie
city: Besançon
country: France
facility: Cabinet Médical
city: Besançon
country: France
facility: Chu Besancon Hopital Jean Minjoz
city: Bois-Guillaume
country: France
facility: Clinique du Cèdre
city: Boulogne-Billancourt
country: France
facility: AP HP Ambroise PARE
city: Boulogne-sur-Mer
country: France
facility: Ch Boulogne Sur Mer
city: Caen
country: France
facility: Hôpital Privé SAINT-MARTIN
city: Cagnes-sur-Mer
country: France
facility: Centre Consultations Polyclinique St Jean
city: Cahors
country: France
facility: Ch Cahors
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante de Lyon
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
city: Chilly-Mazarin
country: France
facility: Cabinet Médical
city: Châteauroux
country: France
facility: Ch Chateauroux
city: Clermont-Ferrand
country: France
facility: CHU CLERMONT FERRAND, site ESTAING
city: Clermont-Ferrand
country: France
facility: Chu Gabriell Monpied
city: Clichy
country: France
facility: AP HP Hôpital BEAUJON
city: Corbeil-Essonnes
country: France
facility: Ch Sud Francilien
city: Ermont
country: France
facility: Clinique Claude BERNARD
city: Gien
country: France
facility: Centre Gastro Loire
city: Haguenau
country: France
facility: Ch Haguenau
city: La Madeleine
country: France
facility: Cabinet Médical
city: Lattes
country: France
facility: Forum Médica
city: Le Coudray
country: France
facility: Ch Chartres Louis Pasteur
city: Le Folgoët
country: France
facility: Cabinet Médical Groupe
city: Le Kremlin-Bicêtre
country: France
facility: AP HP Hôpital BICETRE
city: Lezignan Corbieres
country: France
facility: Cabinet Médical de Rhumatologie
city: Limoges
country: France
facility: Chu Dupuytren 2
city: Lorient
country: France
facility: Ch Bretagne Sud
city: Lunéville
country: France
facility: Medipole de La Meurthe - Cabinet Médical
city: Lyon
country: France
facility: Cabinet Médical TILSITT
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz Cabinet Medica
city: Marolles-en-Brie
country: France
facility: Maison Médicale
city: Marseille
country: France
facility: Centre Mutualiste LA FEUILLERAIE
city: Marseille
country: France
facility: AP HM Hôpital NORD
city: Mennecy
country: France
facility: Cabinet de Rhumatologie
city: Montauban
country: France
facility: Ch Montauban
city: Montauban
country: France
facility: Clinique PONT DE CHAUME
city: Montereau-fault-yonne
country: France
facility: MIMOUNE
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil
city: Nantes
country: France
facility: Chu Hôtel Dieu
city: Neuilly-sur-Seine
country: France
facility: Institut Des Mici-Clinique Ambroise Paré
city: Nice
country: France
facility: Cabinet Médical
city: Nice
country: France
facility: Chu Nice Hôpital Pasteur
city: Paris
country: France
facility: AP HP Hôpital LARRIBOISIERE
city: Paris
country: France
facility: AP HP Hôpital SAINT ANTOINE
city: Paris
country: France
facility: Cabinet Médical
city: Paris
country: France
facility: Ap Hp Gh Pitie Salpetriere
city: Paris
country: France
facility: Cabinet Médical
city: Paris
country: France
facility: Chu Cochin
city: Paris
country: France
facility: Chu Bichat
city: Pierre-Bénite
country: France
facility: Ch Lyon Sud
city: Poissy
country: France
facility: Cabinet Médical
city: Poitiers
country: France
facility: Cabinet Médical
city: Quint-Fonsegrives
country: France
facility: Clinique CROIX du SUD
city: Reims
country: France
facility: Hôpital Robert DEBRE
city: Rennes
country: France
facility: Chu Pontchaillou
city: Rodez
country: France
facility: Cabinet Médical
city: Saint-Amand-les-Eaux
country: France
facility: Cabinet Médical
city: Saint-Avold
country: France
facility: Hôpital St-Avold Groupe Sos Santé
city: Saint-Louis
country: France
facility: Cabinet Médical
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées BEGIN
city: Saint-Étienne
country: France
facility: Chu Saint Etienne Hôpital Nord
city: Sarreguemines
country: France
facility: Cabinet Médical
city: Sarreguemines
country: France
facility: Cabinet Médical
city: Strasbourg
country: France
facility: Cabinet Médical
city: Strasbourg
country: France
facility: Cabinet Médical
city: Strasbourg
country: France
facility: Ch Strasbourg Hôpital Hautepierre
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Tarbes
country: France
facility: Ch Tarbes Lourdes
city: Thionville
country: France
facility: Hôpital Bel Air
city: Toulon
country: France
facility: Cabinet Médical
city: Toulon
country: France
facility: HIA Hôpital SAINT-ANNE
city: Toulouse Cedex
country: France
facility: Clinique PASTEUR
city: Toulouse
country: France
facility: CHU PURPAN Hôpital PIERRE PAUL RIQUET
city: Toulouse
country: France
facility: Chu Rangueil
city: Toulouse
country: France
facility: Clinique MEDIPOLE GARONNE
city: Toulouse
country: France
facility: Clinique PASTEUR
city: Tourcoing
country: France
facility: Cabinet Médical
city: Trévou-Tréguignec
country: France
facility: Centre Rééd. Fonct. Trestel - Ch Lannion
city: Valence
country: France
facility: Hpda Site Clinique Générale
city: Valenciennes
country: France
facility: Cabinet de Rhumatologie
city: Vannes
country: France
facility: Cabinet Médical
city: Vannes
country: France
facility: Cabinet Médical
city: Villeneuve-sur-Lot
country: France
facility: Ch Villeneuve Pôle de Sante Villeneuvois
city: Villeurbanne
country: France
facility: Cabinet Médical
city: Vénissieux
country: France
facility: Ghm Les Portes Du Sud
city: Échirolles
country: France
facility: Chu Grenoble Sud
city: Épagny
country: France
facility: Ch Annecy Genevois
city: Pointe à Pitre
country: Guadeloupe
facility: Cabinet Médical
city: Saint Pierre
country: Martinique
facility: Cabinet Médical
Study officials:
References: