Clinnova-RD: A Prospective Cohort Study of Patients With Rheumatoid Diseases: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care
Trial ID: NCT06235684
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-04-01
Completion date: 2032-05-01
Sponsor: Luxembourg Institute of Health
Collaborators: Luxembourg National Research Fund; Hôpitaux Robert Schuman Luxembourg; University of Luxembourg
Conditions: Rheumatoid Diseases
Interventions: Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

Summary:
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:
Inclusion criteria:

● Signed informed consent form

* ≥ 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
* Either newly diagnosed with a RD as defined in the diseases of interest below\* requiring initiation of therapy OR treatment change , as per physician's discretion OR any increase in disease activity assessed by the rheumatologist to be relevant (e.g., flare(s) before the study visit) \*For RA:
* 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

  * For SLE:

    * Participants fulfilling the 2019 ACR/EULAR Classification Criteria of Systemic Lupus Erythematosus (SLE)
  * For SSc:

    • Participants fulfilling the 2013 ACR/EULAR Classification Criteria for Systemic Sclerosis (Ssc)
  * For ASSD:

    * Participants fulfilling the 2010 Connor's criteria for ASSD

Exclusion criteria

1. 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)
2. Not fluent in any of the following languages: French, English or German
3. Known pregnancy Note: If the participant is pregnant after inclusion and/or follow-up, this is not a reason for withdrawal.
4. Participation in a prospective randomised interventional trial
5. Decrease of disease activity
6. Treatment change due to the unavailability of medication
7. Treatment change due to safety reasons
8. Disease-specific exclusion criteria:

For RA:

• overlap of RA with any other rheumatic/immunologic disease

For SLE:

* overlap of SLE with any other rheumatic/immunologic disease

For SSc:

* overlap of SSc with any other rheumatic/immunologic disease
* other forms of SSc than diffuse cutaneous or limited cutaneous systemic sclerosis

For ASSD:

* overlap of ASSD with any other rheumatic/immunologic disease
* other forms of myositis

Outcomes:
To identify clinical, epidemiological and omics characteristics associated with RD