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)
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)
Emotional state	Month 12	Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.

Trial Locations

Locations (72)

Nouvelle Clinique BONNEFON; 🇫🇷 Alès, France

Ch Amiens Nord; 🇫🇷 Amiens, France

Chu Amiens Picardie Site Sud; 🇫🇷 Amiens, France

Cabinet Médical; 🇲🇶 Saint Pierre, Martinique

Ch Armentieres; 🇫🇷 Armentières, France

CH d'ARDECHE MERDIONALE; 🇫🇷 Aubenas, France

Cabinet de Gastroentérologie; 🇫🇷 Bayonne, France

Chu Besancon Hopital Jean Minjoz; 🇫🇷 Besançon, France

Clinique du Cèdre; 🇫🇷 Bois-Guillaume, France

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

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