A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response (OPALE)

Fresenius Kabi

Status: Completed

Conditions: Psoriasis; Psoriatic Arthritis; Ulcerative Colitis; Ankylosing Spondylitis; Crohn Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05051943

ADAL-001-CNI

Details and patient eligibility

About

The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.

Enrollment: 754 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data
• A disorder treated with anti-TNF therapy
• Whose physician made the decision to initiate adalimumab treatment prior to the study

Exclusion criteria

• Patients participating in an interventional therapeutic trial at the time of inclusion
• Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French