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NCT05051943 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

— OPALE  

Official title:
A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05051943
Other study ID # ADAL-001-CNI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 29, 2020
Est. completion date January 20, 2023

Study information
Verified date July 2023
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 754
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy

Sponsors (1)
Lead Sponsor Collaborator
Fresenius Kabi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 months
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