About this trial
This study is part of the Clinnova program. This is a prospective cohort study including patients with RD recruited at the time of a treatment change. At least 800 participants (recruited in France, Germany and Luxembourg) will be enrolled, of which 100 participants are expected to be recruited in Luxembourg with the present study protocol. The mission of Clinnova is to support the digitalization of healthcare and precision medicine by creating a data-enabling environment for accessing, sharing and analyzing interoperable, high-quality health data. The main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological, and omics data. Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.
Eligibility criteria
Qualifiers
≥ 18 years of age
Willing and able to comply with the protocol for the duration of the study including data and samples collection, study visits and examinations
Participants fulfilling the 2010 ACR/EULAR criteria for RA
Newly diagnosed RA in the last 2 years requiring initiation/change of therapy OR any type of RA requiring treatment change
Disqualifiers
Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits (such as mental disability that makes it difficult or impossible to answer questionnaires)
Not fluent in any of the following languages: French, English or German
Known pregnancy Note: If the participant is pregnant after inclusion and/or follow-up, this is not a reason for withdrawal.
Participation in a prospective randomised interventional trial
Trial design
Treatments tested in this trial
- Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Treatment groups
Locations
Sponsors and collaborators
Luxembourg Institute of Health
Lead sponsor
Luxembourg National Research Fund
Collaborator
Hôpitaux Robert Schuman Luxembourg
Collaborator
University of Luxembourg
Collaborator