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

Fresenius Kabi, France600 enrolled

Overview

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. * 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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Crohn Disease Ulcerative Colitis Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

NOT_YET_RECRUITING

Ch Amiens Nord

Amiens, France

RECRUITING

Chu Amiens Picardie Site Sud

Amiens, France

RECRUITING

Cabinet Médical

Argeles, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Eligibility

Locations (96)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts