Trial · NCT04410978
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses | Baseline (Day 1) to approximately 48 months | The intent-to-treat (ITT) population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | relapses per participant year | NUMBER |
| SECONDARY | Time to Onset of 6-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | Baseline (Day 1) to approximately 48 months | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | months | MEDIAN |
| SECONDARY | Time to Onset of 3-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | Baseline (Day 1) to approximately 48 months | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | months | MEDIAN |
| SECONDARY | Mean Number of New and/or Enlarging T2-Hyperintense Lesions Per Year | Baseline (Day 1) to approximately 48 months | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | number of new and or enlarging T2lesions | MEAN |
| SECONDARY | Mean Number of New Gadolinium-Enhancing T1-Hyperintense Lesions Per Scan | Baseline (Day 1) to approximately 48 months | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | number of new Gd-enhancing T1 lesions | MEAN |
| SECONDARY | Change From Baseline in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test Second Edition (CVLT-II) at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of 6-Month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale | Baseline (Day 1) to approximately 48 months | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | months | MEDIAN |
| SECONDARY | Percent Change in Brain Volume Loss at EOS Compared to Month 6 | Month 6 to EOS (up to approximately 48 months) | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Multiple Sclerosis Quality of Life 54 (MSQoL-54) Questionnaire Score at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints for the specified categories are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), TEAEs Leading to Permanent Study Intervention Discontinuation and Treatment-emergent Adverse Events of Special Interest (AESIs) | From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Tolebrutinib and M2 Metabolite | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | nanogram/milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration (Tmax) of Tolebrutinib and M2 Metabolite | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | hour (h) | MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve Over the Last 24-hours Dosing Interval (AUC0-24) of Tolebrutinib and M2 Metabolite | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | ng*h/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | picogram/mL | MEDIAN |
| SECONDARY | Change From Baseline in Cluster of Differentiation (CD)19+ B Cells at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints are reported. | cells/microliter | MEDIAN |
| SECONDARY | Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS | Baseline (Day 1) to EOS (up to approximately 48 months) | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | gram/liter | MEDIAN |
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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