Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part |
Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable. |
Baseline up to Week 24 |
|
| Secondary |
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part |
Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable. |
Baseline up to Week 24 |
|
| Secondary |
Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part |
Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or >=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable. |
Baseline up to Week 24 |
|
| Secondary |
Annualized Relapse Rate (ARR) - Core Part |
ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable. |
Baseline up to Week 24 |
|
| Secondary |
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part |
Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples. |
Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24 |
|
| Secondary |
B-cell Counts - Japan vs Non-Japan - Core Part |
Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory. |
Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24 |
|
| Secondary |
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part |
Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans. |
Week 24 up to Week 48 |
|
| Secondary |
Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part |
Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25. |
Week 24 up to Week 48 |
|
| Secondary |
Annualized Relapse Rate (ARR) - Extension Part |
ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25. |
Week 24 up to Week 48 |
|
| Secondary |
Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part |
Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples. |
Weeks 24, 28, 36, 48 |
|
| Secondary |
B-cell Counts - Extension Part |
Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory. |
Weeks 24, 36 and 48 |
|
| Secondary |
Participants With Confirmed Relapse - Core and Extension Parts |
A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). |
Baseline up to Week 48 |
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