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

Launched by LUXEMBOURG INSTITUTE OF HEALTH · Jan 23, 2024

Keywords

ClinConnect Summary

The Clinnova-RD study is looking to improve the treatment of rheumatoid diseases, which include conditions like rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. The goal is to understand how changes in treatment can be better predicted using specific markers from medical data. This study will involve at least 800 participants from France, Germany, and Luxembourg, with around 100 people expected to join from Luxembourg. By collecting and analyzing health data, researchers hope to find new ways to tailor treatments to individual patients more effectively.

To participate, individuals must be at least 18 years old, willing to follow the study procedures, and either newly diagnosed with a rheumatoid disease or experiencing a change in their treatment due to worsening symptoms. Participants will need to sign a consent form and will be monitored throughout the study. This study is not yet recruiting, but it aims to gather valuable information that could lead to better treatment options and improved health outcomes for patients with these conditions. If you have any questions or think you might be eligible, it’s a good idea to talk to your healthcare provider.

Gender

ALL

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