Search / Trial NCT06235684

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

Launched by LUXEMBOURG INSTITUTE OF HEALTH · Jan 23, 2024

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Artificial Intelligence Personalized Medicine Treatment Change Phenotyping

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 monitor...

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

About Luxembourg Institute Of Health

The Luxembourg Institute of Health (LIH) is a leading research institution dedicated to advancing health and biomedical sciences through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, LIH focuses on addressing pressing public health challenges and improving patient outcomes. The institute is committed to integrating scientific discovery with clinical application, fostering a robust ecosystem for research excellence in Luxembourg and beyond. By leveraging state-of-the-art facilities and expertise, LIH aims to contribute significantly to the field of health research, promoting evidence-based practices and enhancing the quality of care.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0