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

NCT06235684 | Not Yet Recruiting

• 1 other identifier: LUX-CLIN-002
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Diseases

Keywords

Artificial Intelligence; Personalized medicine; Treatment change; Phenotyping

Outcome Measures

Primary Outcomes (1)

• To identify clinical, epidemiological and omics characteristics associated with RD

  2031

Secondary Outcomes (1)

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

  2031

Other Outcomes (1)

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

  2031

Study Arms (1)

Single Arm study

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

Interventions

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

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.

Single Arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ● 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

You may not qualify if:

• 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
• Participation in a prospective randomised interventional trial
• Decrease of disease activity
• Treatment change due to the unavailability of medication
• Treatment change due to safety reasons
• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• FNR (Luxembourg National Research Fund): collaborator
• Hôpitaux Robert Schuman Luxembourg: collaborator
• University of Luxembourg: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine, saliva, hair, Synovial fluid from Standard Of care

Central Study Contacts

Jasmin Schulz, PhD

CONTACT

+35226970265; Jasmin.Schulz@lih.lu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: September 9, 2025

Record last verified: 2025-09