Trial · NCT05156281
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized relapse rate (ARR) of confirmed relapses [Core Part] | From Baseline, up to 30 months | ARR is the average number of confirmed MS relapses in a year |
| Secondary | Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data) | Baseline up to 30 months | Time to 3-month confirmed disability progression (3mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months |
| Secondary | Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data) | Baseline up to 30 months | Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months |
| Secondary | Annualized rate of new or enlarging T2 lesion [Core Part] | Baseline up to 30 months | Number of new/newly enlarged T2 lesions per year |
| Secondary | Neurofilament light chain (Nfl) [Core Part] | Baseline up to 30 months | Neurofilament light chain (NfL) concentration in serum |
| Secondary | Number of Gd-enhancing T1 lesions per MRI scan [Core Part] | Baseline up to 30 months | Average number of Gd-enhancing T1 lesions per scan |
| Secondary | Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data) | Baseline up to 30 months | Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI |
| Secondary | Time to first confirmed relapse [Core Part] | Baseline up to 30 months | Change in the Expanded Disability Status Scale (EDSS), an increase of at least 0.5 points on the EDSS (total) score, or an increase of at least 1 point on at least two functional scores (FSs), or an increase of at least 2 points on at least one FS, excluding changes involving bowel/bladder or cerebral FS, compared to the previous available rating. |
| Secondary | Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data) | Baseline up to 30 months | Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months |
| Secondary | Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data) | Baseline up to 30 months | Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression eve |
| Secondary | Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data) | Baseline up to 30 months | Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening |
| Secondary | Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data) | Baseline, up to 30 months | The patient walking speed to cover 25-foot distance is recorded in seconds. Longer time indicates poorer lower limb function. 20% worsening is defined as 20% increase from baseline T25FW score |
| Secondary | Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data) | Baseline up to 30 months | The patient's right and left arm function to peg 9 holes measured in seconds. Longer time indicates poorer upper limb function. 20% worsening is defined as 20% increase from baseline 9HPT score in at least one hand (average of two trials per hand) |
| Secondary | Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data) | Baseline up to 30 months | The composite involves CDP and worsening by at least 20% in T25FW and 9HPT |
| Secondary | Change from Baseline in T2 lesion volume [Core Part] | Baseline up to 30 months | Change from baseline in total T2 lesion volume. |
| Secondary | Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part] | Baseline up to 30 months | 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life |
| Secondary | Number of participants with Adverse events and Serious adverse events(SAE) [Core Part] | Baseline up to 30 months | Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating |
| Secondary | Pharmacokinetics of remibrutinib [Core Part] | Month 1, Month 6 | Blood concentrations of remibrutinib |
| Secondary | Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part] | Day 1 Extension up to 5 years | Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating |
| Secondary | Annualized relapse rate (ARR) of confirmed relapses [Extension Part] | Day 1 Extension up to 5 years | ARR is the average number of confirmed MS relapses in a year |
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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