Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06280755
Other study ID # ICO-S-002
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date April 2027

Study information

Verified date February 2024
Source icometrix
Contact Jelle Praet, PhD
Phone +32 16 369 000
Email jelle.praet@icometrix.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.


Description:

There is a clear need for a data-driven and personalized treatment optimisation tool for people with Multiple Sclerosis (MS), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. While early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. The latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening. With the RECLAIM study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, RECLAIM aims to develop MRI-based tools to better monitor disease progression in people with MS, as well as AI-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based MS progression model, (ii) an MRI-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 7000
Est. completion date April 2027
Est. primary completion date April 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS. - Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)/Ethical Committee (EC) approval in accordance with national and local subject privacy regulations. Exclusion criteria: - Patients under 18 years of age will be excluded. - Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study.

Study Design


Locations

Country Name City State
n/a

Sponsors (13)

Lead Sponsor Collaborator
icometrix Aalto University, AB Science, Bristol-Myers Squibb, Casa di Cura IGEA, Charite University, Berlin, Germany, General University Hospital, Prague, Hoffmann-La Roche, Imcyse SA, Nocturne UG, Ruhr University of Bochum, Technische Universität Dresden, University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary The number of patients from each institution who have contributed data to the database. 4 years
Primary The number of patients from each institution whose data was mapped to the common data model of the harmonised database. 4 years
Primary The number of patients from the control arms of clinical trials who have contributed data to the database. 4 years
Primary The data completeness of each variable in the harmonised database. 4 years
Secondary The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level 4 years
Secondary The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable. 4 years
Secondary The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured). 4 years
Secondary The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable. 4 years
Secondary The presence of contextual information on standard data gathering and analysis processes of each institution 4 years
Secondary The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient. 4 years
Secondary The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient. 4 years
Secondary The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines. 4 years
Secondary The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis. 4 years
Secondary The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day. 4 years
Secondary The percentage of patients with a complete disease history available, from the date of diagnosis to the current day. 4 years
Secondary The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT. Each of these scores will be assessed individually for the amount of erroneous or impossible data entries, as well as for the average time between subsequent assessments of each variable. 4 years
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4