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

Recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

• Registration Number: NCT05598684
• Lead Sponsor: Fresenius Kabi, France

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

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-28
• Study Start: 2022-11-24
• Status Verified: 2023-07
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discontinuation of the biosimilar	Month 12	Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Persistence of the biosimilar	Month 12	Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period

Secondary Outcome Measures

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

Trial Locations

Locations (72)

Ch Amiens Nord; 🇫🇷 Amiens, France

Nouvelle Clinique BONNEFON; 🇫🇷 Alès, France

Chu Amiens Picardie Site Sud; 🇫🇷 Amiens, France

Ch Armentieres; 🇫🇷 Armentières, France

Cabinet Médical; 🇲🇶 Saint Pierre, Martinique

CH d'ARDECHE MERDIONALE; 🇫🇷 Aubenas, France

Chu Besancon Hopital Jean Minjoz; 🇫🇷 Besançon, France

Clinique du Cèdre; 🇫🇷 Bois-Guillaume, France

AP HP Ambroise PARE; 🇫🇷 Boulogne-Billancourt, France

Ch Cahors; 🇫🇷 Cahors, France

Ch Boulogne Sur Mer; 🇫🇷 Boulogne-sur-Mer, France

Hôpital Privé SAINT-MARTIN; 🇫🇷 Caen, France

Infirmerie Protestante de Lyon; 🇫🇷 Caluire-et-Cuire, France

Chu Gabriell Monpied; 🇫🇷 Clermont-Ferrand, France

Clinique du Parc; 🇫🇷 Castelnau-le-Lez, France

Ch Chateauroux; 🇫🇷 Châteauroux, France

AP HP Hôpital BEAUJON; 🇫🇷 Clichy, France

Ch Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Clinique Claude BERNARD; 🇫🇷 Ermont, France

Centre Gastro Loire; 🇫🇷 Gien, France

Cabinet Médical Groupe; 🇫🇷 Le Folgoët, France

Forum Médica; 🇫🇷 Lattes, France

Ch Chartres Louis Pasteur; 🇫🇷 Le Coudray, France

Ch Haguenau; 🇫🇷 Haguenau, France

Cabinet Médical de Rhumatologie; 🇫🇷 Lezignan Corbieres, France

AP HP Hôpital BICETRE; 🇫🇷 Le Kremlin-Bicêtre, 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

Centre Mutualiste LA FEUILLERAIE; 🇫🇷 Marseille, France

AP HM Hôpital NORD; 🇫🇷 Marseille, France

Cabinet de Rhumatologie; 🇫🇷 Valenciennes, France

Ch Montauban; 🇫🇷 Montauban, France

MIMOUNE; 🇫🇷 Montereau-fault-yonne, France

Clinique PONT DE CHAUME; 🇫🇷 Montauban, France

Chu Nice Hôpital Pasteur; 🇫🇷 Nice, France

Chu Hôtel Dieu; 🇫🇷 Nantes, France

Institut Des Mici-Clinique Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, France

Ghi Le Raincy Montfermeil; 🇫🇷 Montfermeil, France

AP HP Hôpital LARRIBOISIERE; 🇫🇷 Paris, France

AP HP Hôpital SAINT ANTOINE; 🇫🇷 Paris, France

Ap Hp Gh Pitie Salpetriere; 🇫🇷 Paris, France

Chu Cochin; 🇫🇷 Paris, France

Clinique CROIX du SUD; 🇫🇷 Quint-Fonsegrives, France

Chu Pontchaillou; 🇫🇷 Rennes, France

Hôpital Robert DEBRE; 🇫🇷 Reims, France

Hôpital St-Avold Groupe Sos Santé; 🇫🇷 Saint-Avold, France

Hôpital d'Instruction des Armées BEGIN; 🇫🇷 Saint-Mandé, France

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

Ch Tarbes Lourdes; 🇫🇷 Tarbes, France

Ch Strasbourg Hôpital Hautepierre; 🇫🇷 Strasbourg, France

Hôpital Bel Air; 🇫🇷 Thionville, France

Clinique PASTEUR; 🇫🇷 Toulouse, France

HIA Hôpital SAINT-ANNE; 🇫🇷 Toulon, France

Centre Rééd. Fonct. Trestel - Ch Lannion; 🇫🇷 Trévou-Tréguignec, France

Chu Rangueil; 🇫🇷 Toulouse, France

Hpda Site Clinique Générale; 🇫🇷 Valence, France

Ch Villeneuve Pôle de Sante Villeneuvois; 🇫🇷 Villeneuve-sur-Lot, France

Cabinet de Gastroentérologie; 🇫🇷 Bayonne, France

Centre Consultations Polyclinique St Jean; 🇫🇷 Cagnes-sur-Mer, France

CHU CLERMONT FERRAND, site ESTAING; 🇫🇷 Clermont-Ferrand, France

Chu Dupuytren 2; 🇫🇷 Limoges, France

Maison Médicale; 🇫🇷 Marolles-en-Brie, France

Ch Lyon Sud; 🇫🇷 Pierre-Bénite, France

Chu Saint Etienne Hôpital Nord; 🇫🇷 Saint-Étienne, France

Clinique MEDIPOLE GARONNE; 🇫🇷 Toulouse, France

Chu Bichat; 🇫🇷 Paris, France

CHU PURPAN Hôpital PIERRE PAUL RIQUET; 🇫🇷 Toulouse, France

Ghm Les Portes Du Sud; 🇫🇷 Vénissieux, France

Chu Grenoble Sud; 🇫🇷 Échirolles, France

Ch Annecy Genevois; 🇫🇷 Épagny, France