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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 | Clinical Trials | Clareo Health

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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

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

NCT05598684•Fresenius Kabi, France

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.)

Locations (96)

Nouvelle Clinique BONNEFON

Alès, France

Ch Amiens Nord

Amiens, France

Chu Amiens Picardie Site Sud

Amiens, France

Cabinet Médical

Argeles, 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

Key Dates

Start Date

November 24, 2022

Primary Completion Date

September 30, 2025

Completion Date

December 30, 2025

Last Updated

June 12, 2024

Enrollment

600

ESTIMATED participants

Conditions

Crohn DiseaseUlcerative ColitisRheumatoid ArthritisAnkylosing SpondylitisPsoriatic Arthritis

Contacts

Carole ROSATI

CONTACT

06 26 42 70 58 carole.rosati@fresenius-kabi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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