Rheumatoid DiseasesClinnova-RDNCT06235684
Clinnova-RD: A Prospective Cohort Study of Patients With Rheumatoid Diseases
An observational study of Rheumatoid Diseases, run by Luxembourg Institute of Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Diseases
- What is being tested?
- Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 1 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Who may be able to join
- ● 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
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- 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
Who cannot join
- 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
- Decrease of disease activity
- Treatment change due to the unavailability of medication
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- Treatment change due to safety reasons
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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:
- Identification of predictive biomarkers for drug response estimation and identification of prognostic biomarkers to estimate the future course of the disease, focusing on participants in whom treatment needs to be changed.
- Improved monitoring of participant well-being. 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.
- Conditions
- Rheumatoid Diseases
- Being tested
- Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
- Keywords
- Artificial Intelligence, Personalized medicine, Treatment change, Phenotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusionOther
Also called All participants will be asked to provide data and samples for collection and analysis.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm study | Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion Receives: Other: Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify clinical, epidemiological and omics characteristics associated with RD
Measured: 2031
Secondary outcomes (1)
To establish a sample and data bank to enable biomedical research.
Measured: 2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startOct 2026 (estimated)
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Luxembourg National Research Fund, Hôpitaux Robert Schuman Luxembourg, University of Luxembourg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235684
- Sponsor's protocol ID
- LUX-CLIN-002
- Acronym
- Clinnova-RD
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06235684
- Acronym / sponsor ID
- Clinnova-RD / LUX-CLIN-002
- Conditions
- Rheumatoid Diseases
- Keywords
- Artificial Intelligence, Personalized medicine, Treatment change, Phenotyping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Luxembourg National Research Fund, Hôpitaux Robert Schuman Luxembourg, University of Luxembourg
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Identification of predictive biomarkers for drug response estimation and identification of prognostic biomarkers to estimate the future course of the disease, focusing on participants in whom treatment needs to be changed.
- Improved monitoring of participant well-being. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm study | – | Other: Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusionEither newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
Key inclusion criteria (12 listed)
- ● 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
Key exclusion criteria (18 listed)
- 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
- Decrease of disease activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusionAlso: All participants will be asked to provide data and samples for collection and analysis.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. | Other | Single Arm study |
Primary outcome
To identify clinical, epidemiological and omics characteristics associated with RD
Time frame: 2031
1 secondary outcome
To establish a sample and data bank to enable biomedical research.
Time frame: 2031
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Diseases, run by Luxembourg Institute of Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmin Schulz, PhD (+35226970265, Jasmin.Schulz@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify clinical, epidemiological and omics characteristics associated with RD (time frame: 2031). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.