Trial Outcomes & Findings for Evaluation of the Onset of Action in Highly Active MS (MAGNIFY) (NCT NCT03364036)
NCT ID: NCT03364036
Last Updated: 2023-03-16
Results Overview
CUA lesions were measured by using MRI scans.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
270 participants
Primary outcome timeframe
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
Results posted on
2023-03-16
Participant Flow
A total of 270 participants were enrolled in the study from different trial sites across14 countries (Austria, Germany, Hungary, Poland, Czechia, Italy, Spain, France, United Kingdom of Great Britain and Northern Ireland, Finland, Sweden, Israel, Australia and Canada).
Participant milestones
| Measure |
Experimental: Mavenclad®
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Overall Study
STARTED
|
270
|
|
Overall Study
Full Analysis Set (FAS)
|
270
|
|
Overall Study
COMPLETED
|
270
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Baseline characteristics by cohort
| Measure |
Experimental: Mavenclad®
n=270 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Age, Continuous
|
37.7 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
246 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · White
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · More than one race
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other · Unknown or Not Reported
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
CUA lesions were measured by using MRI scans.
Outcome measures
| Measure |
Experimental: Mavenclad®
n=252 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
|
-1.211 lesions
Standard Deviation 3.4413
|
PRIMARY outcome
Timeframe: Baseline period (the period screening to Baseline), Period 2 (Month 2-6)Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
CUA lesions were measured by using MRI scans.
Outcome measures
| Measure |
Experimental: Mavenclad®
n=252 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
|
-1.521 lesions
Standard Deviation 4.0558
|
PRIMARY outcome
Timeframe: Baseline period (the period screening to Baseline), Period 3 (Month 3-6)Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
CUA lesions were measured by using MRI scans.
Outcome measures
| Measure |
Experimental: Mavenclad®
n=246 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
|
-1.499 lesions
Standard Deviation 3.4244
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 15, 18 and 24Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified categories.
B cell population counts are: CD19 B cells (TBNK panel), CD20 B cells (B cell panel), Memory B cells (B cell panel), Activated B cells (B cell panel), Total plasma cells (B cell panel), Short-lived plasma cells (B cell panel), Naïve B cells (B cell panel), Transitional B cells (B cell panel), and Regulatory B cells (B cell panel).
Outcome measures
| Measure |
Experimental: Mavenclad®
n=204 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 3
|
-80.14 Percent change
Interval -85.85 to -73.65
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 6
|
-60.60 Percent change
Interval -72.43 to -45.62
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 12
|
-26.88 Percent change
Interval -46.67 to -3.7
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 15
|
-77.24 Percent change
Interval -85.64 to -65.59
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 18
|
-55.30 Percent change
Interval -69.55 to -39.3
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD19 B cells (TBNK panel), Month 24
|
-27.65 Percent change
Interval -46.11 to 1.77
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 3
|
-80.50 Percent change
Interval -86.46 to -74.23
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 6
|
-60.32 Percent change
Interval -71.94 to -43.77
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 12
|
-24.56 Percent change
Interval -45.77 to -2.54
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 15
|
-77.11 Percent change
Interval -85.54 to -65.25
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 18
|
-54.21 Percent change
Interval -68.62 to -36.91
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
CD20 B cells (B cell panel), Month 24
|
-24.77 Percent change
Interval -43.43 to 8.84
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 3
|
-92.69 Percent change
Interval -95.56 to -88.52
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 6
|
-91.56 Percent change
Interval -94.14 to -86.8
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 12
|
-86.90 Percent change
Interval -91.57 to -80.14
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 15
|
-96.47 Percent change
Interval -97.75 to -93.25
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 18
|
-94.67 Percent change
Interval -96.7 to -91.41
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Memory B cells (B cell panel), Month 24
|
-89.29 Percent change
Interval -93.61 to -84.91
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 3
|
-74.02 Percent change
Interval -83.29 to -61.45
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 6
|
-60.91 Percent change
Interval -74.77 to -38.25
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 12
|
-28.82 Percent change
Interval -52.68 to -1.85
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 15
|
-73.02 Percent change
Interval -83.81 to -62.22
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 18
|
-51.87 Percent change
Interval -65.0 to -28.54
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Activated B cells (B cell panel), Month 24
|
-15.95 Percent change
Interval -40.82 to 29.33
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 3
|
-66.62 Percent change
Interval -82.38 to -33.69
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 6
|
-59.00 Percent change
Interval -78.63 to -28.51
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 12
|
-54.75 Percent change
Interval -71.43 to -19.03
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 15
|
-78.02 Percent change
Interval -89.68 to -60.13
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 18
|
-72.39 Percent change
Interval -84.71 to -57.31
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Total plasma cells (B cell panel), Month 24
|
-62.47 Percent change
Interval -80.79 to -36.26
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 3
|
-68.18 Percent change
Interval -84.72 to -43.46
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 6
|
-56.55 Percent change
Interval -77.83 to -31.98
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 12
|
-56.70 Percent change
Interval -76.2 to -23.22
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 15
|
-82.96 Percent change
Interval -93.23 to -69.9
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 18
|
-79.54 Percent change
Interval -90.76 to -65.7
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Short-lived plasma cells (B cell panel), Month 24
|
-70.10 Percent change
Interval -83.17 to -45.12
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 3
|
-75.87 Percent change
Interval -84.21 to -66.18
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 6
|
-45.87 Percent change
Interval -61.72 to -24.82
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 12
|
1.63 Percent change
Interval -20.85 to 35.59
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 15
|
-69.17 Percent change
Interval -79.4 to -51.59
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 18
|
-39.73 Percent change
Interval -57.61 to -5.27
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Naïve B cells (B cell panel), Month 24
|
10.85 Percent change
Interval -21.0 to 45.19
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 3
|
-4.06 Percent change
Interval -38.65 to 56.25
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 6
|
14.82 Percent change
Interval -28.68 to 63.34
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 12
|
11.92 Percent change
Interval -26.75 to 64.99
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 15
|
28.69 Percent change
Interval -29.88 to 92.02
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 18
|
11.27 Percent change
Interval -22.94 to 67.22
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Transitional B cells (B cell panel), Month 24
|
6.30 Percent change
Interval -27.06 to 69.12
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 3
|
110.73 Percent change
Interval 17.78 to 290.5
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 6
|
92.95 Percent change
Interval 19.07 to 231.41
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 12
|
30.64 Percent change
Interval -18.33 to 134.17
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 15
|
91.57 Percent change
Interval 15.05 to 288.71
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 18
|
33.83 Percent change
Interval -21.55 to 150.29
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Regulatory B cells (B cell panel), Month 24
|
1.62 Percent change
Interval -36.85 to 98.81
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 15, 18 and 24Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified categories.
T cell population counts are: Total CD4 T cells (TBNK panel), CD4 Th1 cells (T cell panel), CD4 Th17 T cells (T cell panel), CD4 Regulatory T cells (T cell panel), and Total CD8 T cells (TBNK panel).
Outcome measures
| Measure |
Experimental: Mavenclad®
n=204 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 3
|
-48.60 Percent change
Interval -62.55 to -37.05
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 6
|
-47.18 Percent change
Interval -59.72 to -34.68
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 12
|
-40.16 Percent change
Interval -55.59 to -27.74
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 15
|
-69.04 Percent change
Interval -79.78 to -58.61
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 18
|
-66.98 Percent change
Interval -75.03 to -55.24
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD4 T cells (TBNK panel), Month 24
|
-57.51 Percent change
Interval -67.54 to -47.47
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 3
|
-44.35 Percent change
Interval -61.62 to -30.01
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 6
|
-43.20 Percent change
Interval -56.95 to -28.94
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 12
|
-35.55 Percent change
Interval -50.76 to -17.71
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 15
|
-63.68 Percent change
Interval -77.41 to -51.43
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 18
|
-63.01 Percent change
Interval -74.41 to -49.62
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th1 cells (T cell panel), Month 24
|
-52.86 Percent change
Interval -62.71 to -40.22
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 3
|
-33.09 Percent change
Interval -53.72 to -15.56
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 6
|
-30.26 Percent change
Interval -46.84 to -10.7
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 12
|
-18.39 Percent change
Interval -38.1 to 10.51
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 15
|
-44.57 Percent change
Interval -59.51 to -28.43
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 18
|
-42.77 Percent change
Interval -55.47 to -18.37
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Th17 T cells (T cell panel), Month 24
|
-31.74 Percent change
Interval -46.81 to -3.84
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 3
|
-25.98 Percent change
Interval -42.82 to -11.42
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 6
|
-29.84 Percent change
Interval -41.82 to -11.66
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 12
|
-25.60 Percent change
Interval -38.18 to -10.45
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 15
|
-48.40 Percent change
Interval -59.8 to -35.82
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 18
|
-48.73 Percent change
Interval -60.71 to -34.86
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
CD4 Regulatory T cells (T cell panel), Month 24
|
-40.30 Percent change
Interval -52.78 to -27.15
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 3
|
-42.33 Percent change
Interval -54.55 to -22.17
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 6
|
-39.42 Percent change
Interval -52.98 to -19.88
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 12
|
-36.28 Percent change
Interval -51.42 to -15.79
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 15
|
-57.08 Percent change
Interval -69.2 to -38.74
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 18
|
-54.44 Percent change
Interval -67.77 to -35.12
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Total CD8 T cells (TBNK panel), Month 24
|
-45.93 Percent change
Interval -58.41 to -30.17
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 15, 18 and 24.Population: FAS included all participants from the ITT set who received at least one dose of the study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified categories.
NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim.
Outcome measures
| Measure |
Experimental: Mavenclad®
n=203 Participants
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 6
|
-22.38 Percent change
Interval -45.67 to 21.71
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 12
|
29.49 Percent change
Interval -18.73 to 116.77
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 15
|
28.42 Percent change
Interval -11.69 to 97.64
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 18
|
71.73 Percent change
Interval 2.68 to 154.75
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 24
|
77.70 Percent change
Interval 18.42 to 175.01
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 3
|
-8.94 Percent change
Interval -36.65 to 31.46
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 6
|
3.72 Percent change
Interval -26.06 to 42.24
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 3
|
3.08 Percent change
Interval -32.82 to 48.59
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 6
|
-8.88 Percent change
Interval -35.6 to 40.41
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 12
|
9.44 Percent change
Interval -38.02 to 65.9
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 15
|
27.70 Percent change
Interval -24.44 to 104.4
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 18
|
7.89 Percent change
Interval -31.6 to 55.64
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ CD56- NK cells, Month 24
|
-21.64 Percent change
Interval -50.92 to 38.15
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 3
|
-32.50 Percent change
Interval -49.49 to -12.61
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 6
|
-21.78 Percent change
Interval -44.93 to 1.81
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 12
|
-8.10 Percent change
Interval -33.88 to 14.37
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 15
|
-28.56 Percent change
Interval -48.73 to -4.9
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 18
|
-21.47 Percent change
Interval -40.28 to 2.74
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16+ NK cells, Month 24
|
-13.76 Percent change
Interval -35.92 to 12.58
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK p46 cells, Month 3
|
-20.85 Percent change
Interval -47.77 to 17.63
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 12
|
2.56 Percent change
Interval -20.62 to 41.41
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 15
|
4.77 Percent change
Interval -23.35 to 49.22
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 18
|
30.13 Percent change
Interval -8.52 to 75.67
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16low CD56bright, Month 24
|
17.21 Percent change
Interval -20.09 to 82.09
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 3
|
-36.13 Percent change
Interval -55.16 to -14.13
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 6
|
-25.61 Percent change
Interval -46.87 to 1.97
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|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 12
|
-11.05 Percent change
Interval -38.53 to 16.63
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 15
|
-35.05 Percent change
Interval -55.45 to -8.85
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 18
|
-24.99 Percent change
Interval -45.87 to -0.29
|
|
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
CD16bright CD56dim, Month 24
|
-12.94 Percent change
Interval -37.36 to 10.95
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Adverse Events
Experimental: Mavenclad®
Serious events: 14 serious events
Other events: 225 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Mavenclad®
n=270 participants at risk
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
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Cardiac disorders
Left ventricular dysfunction
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0.37%
1/270 • From baseline up to Month 45
|
|
Eye disorders
Diplopia
|
0.37%
1/270 • From baseline up to Month 45
|
|
Eye disorders
Eye haemorrhage
|
0.37%
1/270 • From baseline up to Month 45
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Eye disorders
Eye pain
|
0.37%
1/270 • From baseline up to Month 45
|
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Gastrointestinal disorders
Gastritis
|
0.37%
1/270 • From baseline up to Month 45
|
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Infections and infestations
Vestibular neuronitis
|
0.37%
1/270 • From baseline up to Month 45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.37%
1/270 • From baseline up to Month 45
|
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Nervous system disorders
Cerebrovascular accident
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0.74%
2/270 • From baseline up to Month 45
|
|
Nervous system disorders
Dizziness
|
0.37%
1/270 • From baseline up to Month 45
|
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Surgical and medical procedures
Carotid endarterectomy
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0.37%
1/270 • From baseline up to Month 45
|
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Ear and labyrinth disorders
Vertigo
|
0.37%
1/270 • From baseline up to Month 45
|
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Injury, poisoning and procedural complications
Hip fracture
|
0.37%
1/270 • From baseline up to Month 45
|
|
Injury, poisoning and procedural complications
Overdose
|
0.37%
1/270 • From baseline up to Month 45
|
|
Nervous system disorders
Ischaemic stroke
|
0.37%
1/270 • From baseline up to Month 45
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/270 • From baseline up to Month 45
|
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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.37%
1/270 • From baseline up to Month 45
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.37%
1/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Interspinous osteoarthritis
|
0.37%
1/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.37%
1/270 • From baseline up to Month 45
|
Other adverse events
| Measure |
Experimental: Mavenclad®
n=270 participants at risk
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
26/270 • From baseline up to Month 45
|
|
General disorders
Fatigue
|
11.5%
31/270 • From baseline up to Month 45
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
57/270 • From baseline up to Month 45
|
|
Infections and infestations
Urinary tract infection
|
11.9%
32/270 • From baseline up to Month 45
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.8%
21/270 • From baseline up to Month 45
|
|
Gastrointestinal disorders
Nausea
|
11.5%
31/270 • From baseline up to Month 45
|
|
Infections and infestations
Oral herpes
|
7.4%
20/270 • From baseline up to Month 45
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
27/270 • From baseline up to Month 45
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.4%
28/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
19/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
30/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
6.3%
17/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.2%
14/270 • From baseline up to Month 45
|
|
Musculoskeletal and connective tissue disorders
Pain in extrimity
|
8.1%
22/270 • From baseline up to Month 45
|
|
Nervous system disorders
Dizziness
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7.4%
20/270 • From baseline up to Month 45
|
|
Nervous system disorders
Headache
|
32.2%
87/270 • From baseline up to Month 45
|
|
Nervous system disorders
Paraesthesia
|
5.6%
15/270 • From baseline up to Month 45
|
|
Psychiatric disorders
Anxiety
|
5.9%
16/270 • From baseline up to Month 45
|
|
Psychiatric disorders
Insomnia
|
5.9%
16/270 • From baseline up to Month 45
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Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place