An observational study in Multiple Sclerosis, NMO Spectrum Disorder and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, sponsored by icometrix. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by icometrix · Observational
Among 251 studies in Multiple Sclerosis with a site in Germany — 26 open to participants now, 48 under way, 15 of them phase 3. Multiple Sclerosis · Germany.
Among the 251 studies in Multiple Sclerosis with a site in Germany, this one has the largest planned enrollment of the 62 observational ones that give a count, is one of 11 that started in 2024, is one of 62 observational ones, reaches primary completion later than 20 of the 47 other live ones, and was the 228th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →26 of the 251 studies in Multiple Sclerosis with a site in Germany are open now, in 12 countries. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →251 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 11 started in 2024.
Median enrollment 260 across the 189 interventional studies, 304 across the 62 observational. Of the 192 that completed or were terminated, 97 (51%) have results posted.
196 of 251 have an industry lead sponsor. The 10 most frequent:
icometrix is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
icometrix has 3 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Multiple Sclerosis with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT07183683Charite University, Berlin, GermanyStimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction | 2026-12-30 |
| NCT06280755icometrixClinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study. | 2027-04 |
| NCT06782490CelgeneA Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity | 2027-05-26 |
Among the 251 studies in Multiple Sclerosis with a site in Germany, from their registry updates:
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.
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.
The study will include patients with a confirmed diagnosis of MS (Thompson et al., 2018), CIS, RIS, NMOSD (Wingerchuck et al., 2015), or MOGAD (Banwell et al., 2023). No other specifications are included. We envision a database that captures the diversity and heterogeneity of the population, in order to address factors influencing disease worsening that have not been investigated yet or have only been investigated to a very limited extent in previous studies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retrospective, real-world clinical data obtained via the 6 participating clinical centers in the study.
Data from the control arms of relevant clinical trials obtained via the 4 participating pharmaceutical partners in the study.
The number of patients from each institution who have contributed data to the database.
Time frame: 4 years
The number of patients from each institution whose data was mapped to the common data model of the harmonised database.
Time frame: 4 years
The number of patients from the control arms of clinical trials who have contributed data to the database.
Time frame: 4 years
The data completeness of each variable in the harmonised database.
Time frame: 4 years
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
Time frame: 4 years
The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable.
Time frame: 4 years
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).
Time frame: 4 years
The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable.
Time frame: 4 years
The presence of contextual information on standard data gathering and analysis processes of each institution
Time frame: 4 years
The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient.
Time frame: 4 years
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.
Time frame: 4 years
The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines.
Time frame: 4 years
The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis.
Time frame: 4 years
The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day.
Time frame: 4 years
The percentage of patients with a complete disease history available, from the date of diagnosis to the current day.
Time frame: 4 years
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.
Time frame: 4 years
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Apr 2027, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.