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

N/ACompletedNCT05051943

Fresenius Kabi754 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

754

Conditions

Crohn Disease Ulcerative Colitis Psoriasis Ankylosing Spondylitis Rheumatoid Arthritis Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical Global Impression (CGI)

The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.

Time frame: 12 months