We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364036
Recruitment Status : Completed
First Posted : December 6, 2017
Results First Posted : May 27, 2021
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: Mavenclad®
Enrollment 270
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).
Pre-assignment Details  
Arm/Group Title Experimental: Mavenclad®
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 270
Full Analysis Set (FAS) 270
Completed 270
Not Completed 0
Arm/Group Title Experimental: Mavenclad®
Hide Arm/Group Description 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 Number of Baseline Participants 270
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants from the intent-to-treat (ITT [ITT population included all participants classified as eligible]) set who received at least one dose of the study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants
37.7  (9.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants
Female
180
  66.7%
Male
90
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants
Hispanic or Latino
7
   2.6%
Not Hispanic or Latino
246
  91.1%
Unknown or Not Reported
17
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Other Number Analyzed 270 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.4%
White
225
  83.3%
More than one race
12
   4.4%
Unknown or Not Reported
30
  11.1%
1.Primary Outcome
Title 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)
Hide Description CUA lesions were measured by using MRI scans.
Time Frame Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 252
Mean (Standard Deviation)
Unit of Measure: lesions
-1.211  (3.4413)
2.Primary Outcome
Title 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)
Hide Description CUA lesions were measured by using MRI scans.
Time Frame Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 252
Mean (Standard Deviation)
Unit of Measure: lesions
-1.521  (4.0558)
3.Primary Outcome
Title 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)
Hide Description CUA lesions were measured by using MRI scans.
Time Frame Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 246
Mean (Standard Deviation)
Unit of Measure: lesions
-1.499  (3.4244)
4.Secondary Outcome
Title Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 204
Median (Inter-Quartile Range)
Unit of Measure: Percent change
CD19 B cells (TBNK panel), Month 3 Number Analyzed 204 participants
-80.14
(-85.85 to -73.65)
CD19 B cells (TBNK panel), Month 6 Number Analyzed 200 participants
-60.60
(-72.43 to -45.62)
CD19 B cells (TBNK panel), Month 12 Number Analyzed 195 participants
-26.88
(-46.67 to -3.70)
CD19 B cells (TBNK panel), Month 15 Number Analyzed 161 participants
-77.24
(-85.64 to -65.59)
CD19 B cells (TBNK panel), Month 18 Number Analyzed 163 participants
-55.30
(-69.55 to -39.30)
CD19 B cells (TBNK panel), Month 24 Number Analyzed 172 participants
-27.65
(-46.11 to 1.77)
CD20 B cells (B cell panel), Month 3 Number Analyzed 200 participants
-80.50
(-86.46 to -74.23)
CD20 B cells (B cell panel), Month 6 Number Analyzed 196 participants
-60.32
(-71.94 to -43.77)
CD20 B cells (B cell panel), Month 12 Number Analyzed 191 participants
-24.56
(-45.77 to -2.54)
CD20 B cells (B cell panel), Month 15 Number Analyzed 159 participants
-77.11
(-85.54 to -65.25)
CD20 B cells (B cell panel), Month 18 Number Analyzed 163 participants
-54.21
(-68.62 to -36.91)
CD20 B cells (B cell panel), Month 24 Number Analyzed 169 participants
-24.77
(-43.43 to 8.84)
Memory B cells (B cell panel), Month 3 Number Analyzed 200 participants
-92.69
(-95.56 to -88.52)
Memory B cells (B cell panel), Month 6 Number Analyzed 196 participants
-91.56
(-94.14 to -86.80)
Memory B cells (B cell panel), Month 12 Number Analyzed 189 participants
-86.90
(-91.57 to -80.14)
Memory B cells (B cell panel), Month 15 Number Analyzed 159 participants
-96.47
(-97.75 to -93.25)
Memory B cells (B cell panel), Month 18 Number Analyzed 162 participants
-94.67
(-96.70 to -91.41)
Memory B cells (B cell panel), Month 24 Number Analyzed 169 participants
-89.29
(-93.61 to -84.91)
Activated B cells (B cell panel), Month 3 Number Analyzed 200 participants
-74.02
(-83.29 to -61.45)
Activated B cells (B cell panel), Month 6 Number Analyzed 196 participants
-60.91
(-74.77 to -38.25)
Activated B cells (B cell panel), Month 12 Number Analyzed 190 participants
-28.82
(-52.68 to -1.85)
Activated B cells (B cell panel), Month 15 Number Analyzed 159 participants
-73.02
(-83.81 to -62.22)
Activated B cells (B cell panel), Month 18 Number Analyzed 163 participants
-51.87
(-65.00 to -28.54)
Activated B cells (B cell panel), Month 24 Number Analyzed 169 participants
-15.95
(-40.82 to 29.33)
Total plasma cells (B cell panel), Month 3 Number Analyzed 200 participants
-66.62
(-82.38 to -33.69)
Total plasma cells (B cell panel), Month 6 Number Analyzed 196 participants
-59.00
(-78.63 to -28.51)
Total plasma cells (B cell panel), Month 12 Number Analyzed 190 participants
-54.75
(-71.43 to -19.03)
Total plasma cells (B cell panel), Month 15 Number Analyzed 155 participants
-78.02
(-89.68 to -60.13)
Total plasma cells (B cell panel), Month 18 Number Analyzed 158 participants
-72.39
(-84.71 to -57.31)
Total plasma cells (B cell panel), Month 24 Number Analyzed 167 participants
-62.47
(-80.79 to -36.26)
Short-lived plasma cells (B cell panel), Month 3 Number Analyzed 200 participants
-68.18
(-84.72 to -43.46)
Short-lived plasma cells (B cell panel), Month 6 Number Analyzed 195 participants
-56.55
(-77.83 to -31.98)
Short-lived plasma cells (B cell panel), Month 12 Number Analyzed 188 participants
-56.70
(-76.20 to -23.22)
Short-lived plasma cells (B cell panel), Month 15 Number Analyzed 158 participants
-82.96
(-93.23 to -69.90)
Short-lived plasma cells (B cell panel), Month 18 Number Analyzed 161 participants
-79.54
(-90.76 to -65.70)
Short-lived plasma cells (B cell panel), Month 24 Number Analyzed 168 participants
-70.10
(-83.17 to -45.12)
Naïve B cells (B cell panel), Month 3 Number Analyzed 200 participants
-75.87
(-84.21 to -66.18)
Naïve B cells (B cell panel), Month 6 Number Analyzed 196 participants
-45.87
(-61.72 to -24.82)
Naïve B cells (B cell panel), Month 12 Number Analyzed 189 participants
1.63
(-20.85 to 35.59)
Naïve B cells (B cell panel), Month 15 Number Analyzed 159 participants
-69.17
(-79.40 to -51.59)
Naïve B cells (B cell panel), Month 18 Number Analyzed 162 participants
-39.73
(-57.61 to -5.27)
Naïve B cells (B cell panel), Month 24 Number Analyzed 169 participants
10.85
(-21.00 to 45.19)
Transitional B cells (B cell panel), Month 3 Number Analyzed 200 participants
-4.06
(-38.65 to 56.25)
Transitional B cells (B cell panel), Month 6 Number Analyzed 196 participants
14.82
(-28.68 to 63.34)
Transitional B cells (B cell panel), Month 12 Number Analyzed 191 participants
11.92
(-26.75 to 64.99)
Transitional B cells (B cell panel), Month 15 Number Analyzed 159 participants
28.69
(-29.88 to 92.02)
Transitional B cells (B cell panel), Month 18 Number Analyzed 163 participants
11.27
(-22.94 to 67.22)
Transitional B cells (B cell panel), Month 24 Number Analyzed 170 participants
6.30
(-27.06 to 69.12)
Regulatory B cells (B cell panel), Month 3 Number Analyzed 200 participants
110.73
(17.78 to 290.50)
Regulatory B cells (B cell panel), Month 6 Number Analyzed 196 participants
92.95
(19.07 to 231.41)
Regulatory B cells (B cell panel), Month 12 Number Analyzed 191 participants
30.64
(-18.33 to 134.17)
Regulatory B cells (B cell panel), Month 15 Number Analyzed 159 participants
91.57
(15.05 to 288.71)
Regulatory B cells (B cell panel), Month 18 Number Analyzed 163 participants
33.83
(-21.55 to 150.29)
Regulatory B cells (B cell panel), Month 24 Number Analyzed 170 participants
1.62
(-36.85 to 98.81)
5.Secondary Outcome
Title Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 204
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Total CD4 T cells (TBNK panel), Month 3 Number Analyzed 204 participants
-48.60
(-62.55 to -37.05)
Total CD4 T cells (TBNK panel), Month 6 Number Analyzed 200 participants
-47.18
(-59.72 to -34.68)
Total CD4 T cells (TBNK panel), Month 12 Number Analyzed 195 participants
-40.16
(-55.59 to -27.74)
Total CD4 T cells (TBNK panel), Month 15 Number Analyzed 161 participants
-69.04
(-79.78 to -58.61)
Total CD4 T cells (TBNK panel), Month 18 Number Analyzed 163 participants
-66.98
(-75.03 to -55.24)
Total CD4 T cells (TBNK panel), Month 24 Number Analyzed 172 participants
-57.51
(-67.54 to -47.47)
CD4 Th1 cells (T cell panel), Month 3 Number Analyzed 203 participants
-44.35
(-61.62 to -30.01)
CD4 Th1 cells (T cell panel), Month 6 Number Analyzed 197 participants
-43.20
(-56.95 to -28.94)
CD4 Th1 cells (T cell panel), Month 12 Number Analyzed 192 participants
-35.55
(-50.76 to -17.71)
CD4 Th1 cells (T cell panel), Month 15 Number Analyzed 159 participants
-63.68
(-77.41 to -51.43)
CD4 Th1 cells (T cell panel), Month 18 Number Analyzed 163 participants
-63.01
(-74.41 to -49.62)
CD4 Th1 cells (T cell panel), Month 24 Number Analyzed 170 participants
-52.86
(-62.71 to -40.22)
CD4 Th17 T cells (T cell panel), Month 3 Number Analyzed 200 participants
-33.09
(-53.72 to -15.56)
CD4 Th17 T cells (T cell panel), Month 6 Number Analyzed 193 participants
-30.26
(-46.84 to -10.70)
CD4 Th17 T cells (T cell panel), Month 12 Number Analyzed 185 participants
-18.39
(-38.10 to 10.51)
CD4 Th17 T cells (T cell panel), Month 15 Number Analyzed 152 participants
-44.57
(-59.51 to -28.43)
CD4 Th17 T cells (T cell panel), Month 18 Number Analyzed 157 participants
-42.77
(-55.47 to -18.37)
CD4 Th17 T cells (T cell panel), Month 24 Number Analyzed 164 participants
-31.74
(-46.81 to -3.84)
CD4 Regulatory T cells (T cell panel), Month 3 Number Analyzed 203 participants
-25.98
(-42.82 to -11.42)
CD4 Regulatory T cells (T cell panel), Month 6 Number Analyzed 197 participants
-29.84
(-41.82 to -11.66)
CD4 Regulatory T cells (T cell panel), Month 12 Number Analyzed 192 participants
-25.60
(-38.18 to -10.45)
CD4 Regulatory T cells (T cell panel), Month 15 Number Analyzed 159 participants
-48.40
(-59.80 to -35.82)
CD4 Regulatory T cells (T cell panel), Month 18 Number Analyzed 163 participants
-48.73
(-60.71 to -34.86)
CD4 Regulatory T cells (T cell panel), Month 24 Number Analyzed 169 participants
-40.30
(-52.78 to -27.15)
Total CD8 T cells (TBNK panel), Month 3 Number Analyzed 204 participants
-42.33
(-54.55 to -22.17)
Total CD8 T cells (TBNK panel), Month 6 Number Analyzed 200 participants
-39.42
(-52.98 to -19.88)
Total CD8 T cells (TBNK panel), Month 12 Number Analyzed 195 participants
-36.28
(-51.42 to -15.79)
Total CD8 T cells (TBNK panel), Month 15 Number Analyzed 161 participants
-57.08
(-69.20 to -38.74)
Total CD8 T cells (TBNK panel), Month 18 Number Analyzed 163 participants
-54.44
(-67.77 to -35.12)
Total CD8 T cells (TBNK panel), Month 24 Number Analyzed 172 participants
-45.93
(-58.41 to -30.17)
6.Secondary Outcome
Title Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Experimental: Mavenclad®
Hide Arm/Group Description:
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 Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: Percent change
CD16+ CD56- NK cells, Month 3 Number Analyzed 203 participants
3.08
(-32.82 to 48.59)
CD16+ CD56- NK cells, Month 6 Number Analyzed 197 participants
-8.88
(-35.60 to 40.41)
CD16+ CD56- NK cells, Month 12 Number Analyzed 192 participants
9.44
(-38.02 to 65.90)
CD16+ CD56- NK cells, Month 15 Number Analyzed 159 participants
27.70
(-24.44 to 104.4)
CD16+ CD56- NK cells, Month 18 Number Analyzed 163 participants
7.89
(-31.60 to 55.64)
CD16+ CD56- NK cells, Month 24 Number Analyzed 170 participants
-21.64
(-50.92 to 38.15)
CD16+ NK cells, Month 3 Number Analyzed 203 participants
-32.50
(-49.49 to -12.61)
CD16+ NK cells, Month 6 Number Analyzed 197 participants
-21.78
(-44.93 to 1.81)
CD16+ NK cells, Month 12 Number Analyzed 192 participants
-8.10
(-33.88 to 14.37)
CD16+ NK cells, Month 15 Number Analyzed 159 participants
-28.56
(-48.73 to -4.90)
CD16+ NK cells, Month 18 Number Analyzed 163 participants
-21.47
(-40.28 to 2.74)
CD16+ NK cells, Month 24 Number Analyzed 170 participants
-13.76
(-35.92 to 12.58)
NK p46 cells, Month 3 Number Analyzed 203 participants
-20.85
(-47.77 to 17.63)
NK p46 cells, Month 6 Number Analyzed 197 participants
-22.38
(-45.67 to 21.71)
NK p46 cells, Month 12 Number Analyzed 192 participants
29.49
(-18.73 to 116.77)
NK p46 cells, Month 15 Number Analyzed 158 participants
28.42
(-11.69 to 97.64)
NK p46 cells, Month 18 Number Analyzed 163 participants
71.73
(2.68 to 154.75)
NK p46 cells, Month 24 Number Analyzed 170 participants
77.70
(18.42 to 175.01)
CD16low CD56bright, Month 3 Number Analyzed 203 participants
-8.94
(-36.65 to 31.46)
CD16low CD56bright, Month 6 Number Analyzed 197 participants
3.72
(-26.06 to 42.24)
CD16low CD56bright, Month 12 Number Analyzed 192 participants
2.56
(-20.62 to 41.41)
CD16low CD56bright, Month 15 Number Analyzed 159 participants
4.77
(-23.35 to 49.22)
CD16low CD56bright, Month 18 Number Analyzed 163 participants
30.13
(-8.52 to 75.67)
CD16low CD56bright, Month 24 Number Analyzed 170 participants
17.21
(-20.09 to 82.09)
CD16bright CD56dim, Month 3 Number Analyzed 203 participants
-36.13
(-55.16 to -14.13)
CD16bright CD56dim, Month 6 Number Analyzed 197 participants
-25.61
(-46.87 to 1.97)
CD16bright CD56dim, Month 12 Number Analyzed 192 participants
-11.05
(-38.53 to 16.63)
CD16bright CD56dim, Month 15 Number Analyzed 159 participants
-35.05
(-55.45 to -8.85)
CD16bright CD56dim, Month 18 Number Analyzed 163 participants
-24.99
(-45.87 to -0.29)
CD16bright CD56dim, Month 24 Number Analyzed 170 participants
-12.94
(-37.36 to 10.95)
Time Frame From baseline up to Month 45
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Mavenclad®
Hide Arm/Group Description 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.
All-Cause Mortality
Experimental: Mavenclad®
Affected / at Risk (%)
Total   0/270 (0.00%) 
Hide Serious Adverse Events
Experimental: Mavenclad®
Affected / at Risk (%)
Total   14/270 (5.19%) 
Cardiac disorders   
Left ventricular dysfunction * 1  1/270 (0.37%) 
Ear and labyrinth disorders   
Vertigo * 1  1/270 (0.37%) 
Eye disorders   
Diplopia * 1  1/270 (0.37%) 
Eye haemorrhage * 1  1/270 (0.37%) 
Eye pain * 1  1/270 (0.37%) 
Gastrointestinal disorders   
Gastritis * 1  1/270 (0.37%) 
Infections and infestations   
Vestibular neuronitis * 1  1/270 (0.37%) 
Injury, poisoning and procedural complications   
Hip fracture * 1  1/270 (0.37%) 
Overdose * 1  1/270 (0.37%) 
Musculoskeletal and connective tissue disorders   
Interspinous osteoarthritis * 1  1/270 (0.37%) 
Lumbar spinal stenosis * 1  1/270 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Papillary thyroid cancer * 1  1/270 (0.37%) 
Nervous system disorders   
Cerebrovascular accident * 1  2/270 (0.74%) 
Dizziness * 1  1/270 (0.37%) 
Ischaemic stroke * 1  1/270 (0.37%) 
Renal and urinary disorders   
Nephrolithiasis * 1  1/270 (0.37%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  1/270 (0.37%) 
Skin and subcutaneous tissue disorders   
Skin lesion * 1  1/270 (0.37%) 
Surgical and medical procedures   
Carotid endarterectomy * 1  1/270 (0.37%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: Mavenclad®
Affected / at Risk (%)
Total   225/270 (83.33%) 
Blood and lymphatic system disorders   
Lymphopenia * 1  28/270 (10.37%) 
Gastrointestinal disorders   
Diarrhoea * 1  26/270 (9.63%) 
Nausea * 1  31/270 (11.48%) 
General disorders   
Fatigue * 1  31/270 (11.48%) 
Infections and infestations   
Nasopharyngitis * 1  57/270 (21.11%) 
Urinary tract infection * 1  32/270 (11.85%) 
Oral herpes * 1  20/270 (7.41%) 
Upper respiratory tract infection * 1  27/270 (10.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  19/270 (7.04%) 
Back pain * 1  30/270 (11.11%) 
Muscle Spasm * 1  17/270 (6.30%) 
Neck Pain * 1  14/270 (5.19%) 
Pain in extrimity * 1  22/270 (8.15%) 
Nervous system disorders   
Dizziness * 1  20/270 (7.41%) 
Headache * 1  87/270 (32.22%) 
Paraesthesia * 1  15/270 (5.56%) 
Psychiatric disorders   
Anxiety * 1  16/270 (5.93%) 
Insomnia * 1  16/270 (5.93%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  21/270 (7.78%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Communication Center
Organization: Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@emdgroup.com
Publications of Results:
de Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S; MAGNIFY-MS Study Group. Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS. Neurol Neuroimmunol Neuroinflamm. 2022 Jun 14;9(4):e1187. doi: 10.1212/NXI.0000000000001187. Print 2022 Jul. Erratum In: Neurol Neuroimmunol Neuroinflamm. 2022 Oct 20;9(6):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03364036    
Other Study ID Numbers: MS700568_0022
2017-002631-42 ( EudraCT Number )
First Submitted: December 1, 2017
First Posted: December 6, 2017
Results First Submitted: May 4, 2021
Results First Posted: May 27, 2021
Last Update Posted: March 16, 2023