Trial · NCT05084638
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | Month 6 to month 18 | A participant is considered as achieved NEDA-3 if they were: * relapse-free, defined as no confirmed relapses in month 6 to 18. * 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18. * MRI activity-free, defined as no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Number of Confirmed MS Relapses in Months 6 to 18 | Month 6 to month 18 | Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS , i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. Confirmation of MS relapse was done centrally. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Participant Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | ARR (participant-based) is calculated at the participant level as \[(number of confirmed MS relapses in Months 6 to 18) / (number of days in Months 6 to 18)\] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Group Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | ARR (group-based) is calculated at the group level as \[(total number of confirmed MS relapses in Months 6 to 18 for all participants within the ofatumumab-treated cohort) / (total number of days in Months 6 to 18 for all participants within the ofatumumab-treated cohort)\] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Percentage of Participants That Were 3-month Disability Progression-free | Month 6 to month 18 | 3-month clinical disability progression-free was defined as no clinical disability progression as measured by EDSS (global assessment scale), where 3-month confirmed clinical disability progression was defined as an increase from Month 6 in EDSS sustained for at least 3 months. If a participant fulfilled the clinical disability progression criteria based on the single EDSS assessment at Month 18, it was considered a confirmed clinical disability progression (sustainment for at least 3 months was not required). If a participant died due to MS , it was considered a confirmed clinical disability progression regardless of the Month 6 EDSS or change in EDSS. Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | Month 6 to month 18 | A participant is considered as achieved NEDA-Clinical if the participant has not had a confirmed MS relapse in Months 6 to 18 and no 3-month confirmed clinical disability progression in Months 6 to 18 (based on change from Month 6 in EDSS). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | Month 6 to month 18 | A participant is considered as achieved NEDA-radiological if the participant has had no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 (MRI activity-free). Scheduled and unscheduled assessments are considered. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Change From Baseline in Gd+ Lesion Count | Baseline to Month 18 and 30 | Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in Gd+ Lesion Volume | Baseline to Month 18 and 30 | Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in New/Enlarging T2 Lesion Count | Baseline to Month 18 and 30 | Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in T2 Lesion Volume | Baseline to Month 18 and 30 | Change in size of T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline for NeuroQOL | Baseline to Month 18 and 30 | The NeuroQOL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following domains will be measured. Physical Health, Mental Health, Social Health. Scales can be scored by summing the values of the response to each item to develop a total raw score. |
| Secondary | Change From Baseline for Patient Determined Disease Steps (PDDS) | Baseline to Month 18 and 30 | The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in multiple sclerosis patients primarily based on ambulation. The questionnaire contains 1 question which is scored ranging from 0 (normal) to 8 (bedridden). A score of 0 to 2 indicates mild disability; a score of 3 to 5 indicates moderate disability; a score of 6 to 8 indicates severe disability. |
| Secondary | Brain Volume Loss (BVL) Assessment (Whole Brain and Regional) | Month 6 to Month 18 and 30 | Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression. Evaluate the effect of ofatumumab vs healthy controls on 1) whole brain and regional atrophy measured at month 18/30 after re-baseline at 6 months; and 2) regional atrophy measured 18/30 months from Baseline |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Baseline up to approximately Month 30 | Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration \> the participant's baseline value or \> the lower limit of normal, whichever is observed first. Other safety assessments (physical exam, vital signs, etc) that meet the definition of an adverse event or are considered clinically relevant by the investigator will be reported as an adverse event. |
| Secondary | Change From Baseline in New Unenhancing T1 Lesion Number | Baseline to Month 18 and 30 | Change in the number of new unenhancing T1 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in T1 Unenhancing Lesion Volume | Baseline to Month 18 and 30 | Change in the size of T1 unenhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
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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