Ankylosing Spondylitis, Crohn Disease, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis
Conditions
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
Interventions
None listed
Sponsors
Fresenius Kabi, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of the biosimilar | Month 12 | Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period |
| Discontinuation of the biosimilar | Month 12 | Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Tolerability evaluation | Month 12 | Collection of all adverse events (serious or non serious) |
| Emotional state | Month 12 | Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire. |
| Maintenance of therapeutic benefit | Month 6 | 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) |
Countries
France, Guadeloupe, Martinique
Contacts
Primary ContactCarole ROSATI
Outcome results
None listed