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Trial · NCT06529406

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNew T2 lesions count36 monthsNumber of new T2 lesions on MRI scans.
PrimarySerious infections36 monthsInfections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.
SecondaryRelapses36 monthsProtocol and/or suspected relapses
SecondaryIgG and IgM levels36 monthsIgG and IgM levels
SecondaryInfections36 monthsAll infections including opportunistic infections.
SecondaryNo Evidence of Disease Activity (NEDA-3)36 months
Not meeting any of the following criteria: 1. Evidence of Relapse activity - collected every 3 months via phone calls/clinic visits. 2. MRI disease activity - presence of new T2 lesions from MRI scans conducted at any timepoint. 3. 6 months Confirmed Disability progression (CDP6): measured by the EDSS assessed at baseline and every 6 months. CDP6 is defined as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0; or ≥1.0 points if baseline EDSS was ≥0.5-≤5.5; or by ≥0.5 points if baseline EDSS ≥6, sustained over two consecutive visits.
SecondaryNeurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)36 monthsNeurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
SecondaryBrain parenchymal and thalamic volume loss36 monthsBrain parenchymal and thalamic volume loss
SecondaryAdverse Events36 monthsAdverse Events
OtherSymbol Digital Modalities Test36 monthsA 4 points or 10% change in cognition
Other9-hole peg test36 monthsA 20% change in hand function
Other25-foot walk speed36 monthsA 20% change in walking speed
OtherMultiple Sclerosis Functional Composite (MSFC)36 monthsA change in any of the above three criteria
OtherPRO outcomes36 monthsInclude treatment satisfaction (TSQM), MS fatigue scale (Modified Fatigue Impact Scale \[MFIS\]), or quality of life (MSIS-29). A minimum of 5% change.
OtherChanges in employment36 months.Changes in employment and full employment status.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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