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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05051943
Acronym
OPALE
Enrollment
754
Registered
2021-09-21
Start date
2020-09-29
Completion date
2023-01-20
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

nutrition

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.

Interventions

None listed

Sponsors

Fresenius Kabi
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Global Impression (CGI)12 monthsThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026