An observational study in Crohn Disease, Ulcerative Colitis and Rheumatoid Arthritis, sponsored by Fresenius Kabi, France. Recruiting at 96 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Fresenius Kabi, France (part of Fresenius Kabi) · Observational
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
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.
Secondary objectives:
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 600 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →This is the only study on the registry with Fresenius Kabi, France as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar
Persistence of the biosimilar
Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period
Time frame: Month 12
Discontinuation of the biosimilar
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Time frame: Month 12
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)
Time frame: Day 0
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)
Time frame: Month 6
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)
Time frame: Month 12
Treatment acceptance
Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire
Time frame: Day 0
Quality of life assessment
Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale
Time frame: Month 12
Emotional state
Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.
Time frame: Month 12
Tolerability evaluation
Collection of all adverse events (serious or non serious)
Time frame: Month 12
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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