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Assessing factors for continuing treatment with a biosimilar of adalimumab in 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

Observational Fresenius Kabi, France · NCT05598684

This study looks at adults in France starting or switching to a new version of adalimumab to see how well it works and why some people might stop using it over a year.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorFresenius Kabi, France Industry-sponsored
Drugs / interventionsadalimumab
Locations96 sites (Alès and 95 other locations)
Trial IDNCT05598684 on ClinicalTrials.gov

What this trial studies

This observational study follows adult patients in France who are starting treatment with adalimumab or switching from Humira® to a biosimilar (Adalimumab FK). Over a 12-month period, the study aims to identify predictive factors that influence the persistence of treatment. Additionally, it will evaluate the therapeutic benefits and tolerability of the biosimilar, as well as document reasons for any treatment discontinuations. The study is conducted under routine medical practice conditions to reflect real-world outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over diagnosed with chronic inflammatory rheumatological or bowel diseases who are starting or switching to adalimumab treatment.

Not a fit: Patients currently enrolled in interventional therapeutic trials or those unable to comply with follow-up procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify factors that improve treatment adherence and outcomes for patients with chronic inflammatory diseases.

How similar studies have performed: While this approach is observational, similar studies have shown success in understanding treatment persistence and patient outcomes with biosimilars.

Eligibility criteria

Show full inclusion / exclusion 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.)

Where this trial is running

Alès and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn DiseaseUlcerative ColitisRheumatoid ArthritisAnkylosing SpondylitisPsoriatic Arthritis
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.