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

Rheumatoid Arthritis Clinical Trial

— SAPHIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598684
• Other study ID #: 2022-A00946-37
• Status: Recruiting
• Start date: November 24, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2023
• Source: Fresenius Kabi, France
• Contact: Carole ROSATI
• Phone: 06 26 42 70 58
• Email: carole.rosati[@]fresenius-kabi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Crohn Disease
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcerative Colitis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi, France

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of the biosimilar	Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period	Month 12
Primary	Discontinuation of the biosimilar	Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab	Month 12
Secondary	Clinical status	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
Secondary	Maintenance of therapeutic benefit	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
Secondary	Maintenance of therapeutic benefit	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
Secondary	Treatment acceptance	Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire	Day 0
Secondary	Quality of life assessment	Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale	Month 12
Secondary	Emotional state	Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.	Month 12
Secondary	Tolerability evaluation	Collection of all adverse events (serious or non serious)	Month 12