MS trials combine relapse counts, disability progression on the EDSS and MRI activity, often with a blinded examining neurologist. Capture structures relapses, EDSS components and scan tracking in one study, with role-based access that keeps raters blind.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Symptom onset date
RLSTDTCSymptoms lasted 24 hours or more
RL24HFever or infection present
RLFEVEREDSS assessment by examining neurologist
RLEDSSWhat matters in MS trials
Study design
A suspected relapse starts a sequence: the participant reports symptoms, the site sees them within a defined window (often a few days), the examining neurologist performs an EDSS, and the investigator decides whether it meets the protocol definition. Treatment with steroids may follow. If any step happens late or is not recorded, the relapse cannot be confirmed and the endpoint loses an event.
Unscheduled relapse visits with their own forms make that sequence visible. The relapse form records onset, duration, fever or infection, the functional systems affected and the confirmation decision; the EDSS form at the same visit records the objective change.
Scans are usually read centrally by an imaging vendor. The study database records scan dates and acquisition details, and the central read results are typically delivered as a dataset and merged for analysis. Check that scan dates in the database and the imaging vendor's records agree.
| Assessment | Scr | BL | M3 | M6 | M12 | M24 | Relapse |
|---|---|---|---|---|---|---|---|
| EDSS (examining neurologist) | |||||||
| Relapse assessment | |||||||
| MRI | |||||||
| Timed 25-foot walk and 9-hole peg | |||||||
| Fatigue PRO |
Relapse visits are unscheduled and use the same forms
Blinding
Roles control what each user sees and does. Blinded roles never receive the treatment arm, not even in the data behind the screen, and emergency unblinding stays available to investigators, with every allocation and unblinding logged in the audit trail. Plan the examining neurologist's role as part of your rater separation, and check in the sandbox exactly what each role can see.
Study coordinator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnNot sent
Unblinded administrator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnA
Same subject, same screen. The arm never reaches blinded roles.
Set up unscheduled relapse visits in the free sandbox.
Endpoints
| Endpoint | Data needed |
|---|---|
| Annualised relapse rate | Relapse forms with onset and confirmation, time on study |
| Confirmed disability progression | EDSS with dates, relapse status at confirmation, confirmation interval |
| MRI activity | Scan dates and central read results |
| Composite progression | EDSS, timed 25-foot walk and nine-hole peg test |
| No evidence of disease activity | Relapses, progression and MRI activity combined |
| Cognition | Processing speed tests such as the SDMT |
Long follow-up
MS treatments are taken for years, so pivotal trials are often followed by open-label extensions that continue collecting EDSS, relapses and safety data. Planning the extension in the same study structure, with the same forms and definitions, keeps the long-term dataset continuous.
Safety monitoring may include specific risks such as infections, liver function or lymphocyte counts, depending on the mechanism. Repeated lab values in a lab table with reference ranges and range checks make trends visible early. See adverse event reporting software.
Study build
Duration, fever exclusion, separation and confirmation rules.
Time from symptom report to examination.
Roles that keep safety and dosing data away.
EDSS thresholds and confirmation interval.
Scan dates and details recorded; central reads merged.
Same forms and definitions for long-term follow-up.
Annualised relapse rate, confirmed disability progression on the EDSS, and MRI activity, with composite progression endpoints in progressive MS.
Typically as new or worsening neurological symptoms lasting at least 24 hours without fever or infection, separated from a previous relapse by at least 30 days. Confirmed relapses usually need an objective change on examination.
To keep the EDSS rater unaware of side effects or dosing that could reveal the treatment arm.
Yes. Blinded roles never receive the treatment arm, and permissions control what each role sees.
Capture records scan dates and details. Images are usually read centrally by an imaging vendor, and results are merged for analysis.
Yes, in the free sandbox with every feature.
Relapses, EDSS and blinded roles in one study. Free sandbox.