A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed
- Conditions
- Ankylosing SpondylitisUlcerative ColitisPsoriatic ArthritisCrohn DiseaseRheumatoid ArthritisPsoriasis
- Registration Number
- NCT05051943
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 754
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Global Impression (CGI) 12 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHRU de Nancy - HĂ´pitaux de Brabois
🇫🇷Vandœuvre-lès-Nancy, France