An observational study in Rheumatoid Diseases, sponsored by Luxembourg Institute of Health. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Luxembourg Institute of Health · Observational
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.
Major unmet clinical needs in RD are participant stratification by the predicted response to different drugs and the stratification of participants by predicted disease course, which might result in more or less aggressive treatment approaches. In this context, key unmet needs that can be addressed by data science and artificial intelligence include:
Luxembourg Institute of Health is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
● Signed form
Newly diagnosed RA in the last 2 years requiring initiation/change of therapy OR any type of RA requiring treatment change
For SLE:
For SSc:
For ASSD:
Exclusion criteria
For RA:
For SLE:
For SSc:
For ASSD:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Other: Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
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.
Also known as: All participants will be asked to provide data and samples for collection and analysis.
To identify clinical, epidemiological and omics characteristics associated with RD
Time frame: 2031
To establish a sample and data bank to enable biomedical research.
Time frame: 2031
To develop applications for better interaction between participants and medical doctors leading to improved healthcare support services.
Time frame: 2031
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for May 2031, 55 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Luxembourg Institute of Health