Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Mavenclad ®, Cladribine
Brief summary
The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).
Interventions
DRUGMavenclad®
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.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Highly active RMS as defined by: * One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs) * Two or more relapses in the previous year, whether on DMD treatment or not. * Expanded Disability Status Scale (EDSS) score less than equals to (\<=) 5.0. * Other protocol defined inclusion criteria could apply.
Exclusion criteria
* Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab. * Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM). * Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result. * Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. * History of tuberculosis , presence of active tuberculosis, or latent tuberculosis * Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI). * Active malignancy or history of malignancy. * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline period (the period screening to Baseline), Period 1 (Month 1-6) | CUA lesions were measured by using MRI scans. |
| 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) | Baseline period (the period screening to Baseline), Period 2 (Month 2-6) | CUA lesions were measured by using MRI scans. |
| 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) | Baseline period (the period screening to Baseline), Period 3 (Month 3-6) | CUA lesions were measured by using MRI scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24 | Baseline, Month 3, 6, 12, 15, 18 and 24 | 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). |
| Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24 | Baseline, Month 3, 6, 12, 15, 18 and 24 | 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). |
| Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24 | Baseline, Month 3, 6, 12, 15, 18 and 24. | NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim. |
Countries
Australia, Austria, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Poland, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 270 |
| Total | 270 |
Baseline characteristics
| Characteristic | Experimental: Mavenclad® |
|---|---|
| Age, Continuous | 37.7 Years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 246 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) Other American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Other Asian | 2 Participants |
| Race (NIH/OMB) Other Black or African American | 1 Participants |
| Race (NIH/OMB) Other More than one race | 12 Participants |
| Race (NIH/OMB) Other Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Other Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) Other White | 225 Participants |
| Sex: Female, Male Female | 180 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 270 |
| other Total, other adverse events | 225 / 270 |
| serious Total, serious adverse events | 14 / 270 |
Outcome results
Primary
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)
CUA lesions were measured by using MRI scans.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Mavenclad® | 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
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)
CUA lesions were measured by using MRI scans.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Mavenclad® | 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
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)
CUA lesions were measured by using MRI scans.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Mavenclad® | 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
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
Secondary
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
Secondary
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |
| Experimental: Mavenclad® | 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 |