Clinnova-RD: A Prospective Cohort Study of Patients With Rheumatoid Diseases

ConditionRheumatoid Diseases

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorLuxembourg Institute of Health

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

This trial does not accept healthy volunteers

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 population

Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Other intervention
During the first year, data related to demographics, lifestyle, laboratory and physical examinations will be collected at baseline, at month 3, at month 12 and in case of unscheduled visit. Questionnaires and standardised voice collection will be collected (optionally) at different time points using the Colive web app. Physical activity and sleep quality will be optionally monitored via a smartwatch that will be provided to interested participants. Biological sample(s) and imaging data will be collected at different time points (baseline; 3 months; 12 months; unscheduled visit). A long-term follow-up (starting from month 12 and up to 4 years after month 12) is foreseen in this study. During the long-term follow-up medical data are collected on a yearly basis, and questionnaires are collected every 6 months.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Single Arm study1 intervention

Trial outcomes

Primary outcomes

To identify clinical, epidemiological and omics characteristics associated with RD

Time frame

2031

Secondary outcomes

To establish a sample and data bank to enable biomedical research.

Time frame

2031

Other outcomes

To develop applications for better interaction between participants and medical doctors leading to improved healthcare support services.

Time frame

2031

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luxembourg Institute of Health

Lead sponsor

Luxembourg National Research Fund

Collaborator

Hôpitaux Robert Schuman Luxembourg

Collaborator

University of Luxembourg

Collaborator

Source ClinicalTrials.gov

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