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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Crohn Disease
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcerative Colitis

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