- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06235684
Clinnova-RD: A Prospective Cohort Study of Patients With Rheumatoid Diseases (Clinnova-RD)
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jasmin Schulz, PhD
- Phone Number: +35226970265
- Email: Jasmin.Schulz@lih.lu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Single Arm study
Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify clinical, epidemiological and omics characteristics associated with RD
Time Frame: 2031
|
2031
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish a sample and data bank to enable biomedical research.
Time Frame: 2031
|
2031
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To develop applications for better interaction between participants and medical doctors leading to improved healthcare support services.
Time Frame: 2031
|
2031
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LUX-CLIN-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Diseases
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
Universidad Autonoma de Nuevo LeonCompletedRheumatoId ArthritisMexico
-
Hamad Medical CorporationUnknownRHEUMATOID ARTHRITISQatar
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
-
The Catholic University of KoreaUnknownRheumatoId Arthritis
Clinical Trials on Either newly diagnosed with a RD requiring initiation of therapy OR treatment change at the time of inclusion
-
University of BolognaAzienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoNot yet recruitingCancer Related Cardiovascular ToxicityItaly, North Macedonia, Serbia
-
IGLESIAS Juan FernandoClinical Trials Unit University of BernNot yet recruitingST Elevation Myocardial InfarctionSwitzerland
-
Memorial Sloan Kettering Cancer CenterPfizer; Dana-Farber Cancer Institute; University of Pittsburgh; University of VirginiaCompletedNeurofibromatosis | Meningioma | CNS Cancer | Hemangioblastoma | Intracranial HemangiopericytomaUnited States
-
Memorial Sloan Kettering Cancer CenterCelgene CorporationCompletedLeukemia | Chronic Lymphocytic LeukemiaUnited States
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted