Trial Outcomes & Findings for Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). (NCT NCT02525874)
NCT ID: NCT02525874
Last Updated: 2019-06-27
Results Overview
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Results posted on
2019-06-27
Participant Flow
This study was conducted from 11 August 2015 to 23 April 2018 in Belgium, Bulgaria, Lithuania, Kuwait, Poland and United States.
A total of 218 participants were enrolled in the study of which 158 participants completed the study
Participant milestones
| Measure |
Dimethyl Fumarate (BG00012)
Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Overall Study
STARTED
|
218
|
|
Overall Study
COMPLETED
|
158
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Dimethyl Fumarate (BG00012)
Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Overall Study
Other
|
1
|
|
Overall Study
Investigator Decision
|
1
|
|
Overall Study
Consent withdrawn
|
22
|
|
Overall Study
Non-compliance with study drug
|
3
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Disease progression, defined by protocol
|
2
|
|
Overall Study
Disease relapse
|
4
|
|
Overall Study
Alternative Treatment for MS
|
2
|
|
Overall Study
New lesions in Brain
|
1
|
Baseline Characteristics
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Baseline characteristics by cohort
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Baseline
|
1318.1 cells per cubic millimeter (cells/mm^3)
Standard Deviation 544.00
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Baseline
|
235.9 cells per cubic millimeter (cells/mm^3)
Standard Deviation 168.88
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 4
|
-18.8 cells per cubic millimeter (cells/mm^3)
Standard Deviation 89.71
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 8
|
-48.2 cells per cubic millimeter (cells/mm^3)
Standard Deviation 122.20
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 12
|
-65.9 cells per cubic millimeter (cells/mm^3)
Standard Deviation 128.53
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 24
|
-76.5 cells per cubic millimeter (cells/mm^3)
Standard Deviation 140.33
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 36
|
-70.1 cells per cubic millimeter (cells/mm^3)
Standard Deviation 104.80
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
B Cells: Change at Week 48
|
-60.7 cells per cubic millimeter (cells/mm^3)
Standard Deviation 115.26
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Baseline
|
184.2 cells per cubic millimeter (cells/mm^3)
Standard Deviation 107.12
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 4
|
6.1 cells per cubic millimeter (cells/mm^3)
Standard Deviation 84.66
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 8
|
-9.0 cells per cubic millimeter (cells/mm^3)
Standard Deviation 89.55
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 12
|
-21.7 cells per cubic millimeter (cells/mm^3)
Standard Deviation 90.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 24
|
-26.9 cells per cubic millimeter (cells/mm^3)
Standard Deviation 88.06
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 36
|
-41.5 cells per cubic millimeter (cells/mm^3)
Standard Deviation 90.37
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
NK Cells: Change at Week 48
|
-42.0 cells per cubic millimeter (cells/mm^3)
Standard Deviation 104.88
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 4
|
-44.8 cells per cubic millimeter (cells/mm^3)
Standard Deviation 383.55
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 8
|
-167.0 cells per cubic millimeter (cells/mm^3)
Standard Deviation 482.86
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 12
|
-284.3 cells per cubic millimeter (cells/mm^3)
Standard Deviation 527.58
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 24
|
-446.7 cells per cubic millimeter (cells/mm^3)
Standard Deviation 542.06
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 36
|
-545.5 cells per cubic millimeter (cells/mm^3)
Standard Deviation 550.87
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
T Cells: Change at Week 48
|
-580.2 cells per cubic millimeter (cells/mm^3)
Standard Deviation 551.52
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Baseline
|
879.0 cells per cubic millimeter (cells/mm^3)
Standard Deviation 400.71
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 4
|
-27.4 cells per cubic millimeter (cells/mm^3)
Standard Deviation 256.21
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 8
|
-95.4 cells per cubic millimeter (cells/mm^3)
Standard Deviation 318.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 12
|
-176.8 cells per cubic millimeter (cells/mm^3)
Standard Deviation 353.52
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 24
|
-269.8 cells per cubic millimeter (cells/mm^3)
Standard Deviation 360.92
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 36
|
-329.7 cells per cubic millimeter (cells/mm^3)
Standard Deviation 374.66
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD4+ T cells: Change at Week 48
|
-352.6 cells per cubic millimeter (cells/mm^3)
Standard Deviation 380.77
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells: Baseline
|
419.5 cells per cubic millimeter (cells/mm^3)
Standard Deviation 203.76
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 4
|
-14.2 cells per cubic millimeter (cells/mm^3)
Standard Deviation 147.21
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 8
|
-65.3 cells per cubic millimeter (cells/mm^3)
Standard Deviation 181.65
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 12
|
-100.4 cells per cubic millimeter (cells/mm^3)
Standard Deviation 193.28
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 24
|
-170.2 cells per cubic millimeter (cells/mm^3)
Standard Deviation 201.14
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 36
|
-201.4 cells per cubic millimeter (cells/mm^3)
Standard Deviation 203.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
CD8+ T cells:Change at Week 48
|
-214.9 cells per cubic millimeter (cells/mm^3)
Standard Deviation 203.62
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell \[CD38+\], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell \[CD38+HLA-DR+\], Activated CD4+ T-cell \[HLA-DR+\], Activated CD8+ T-cell \[HLA-DR+\], Central Memory (CM) CD4+ T-cell \[CD45RA-CCR7+\], CM CD4+ T-cell \[CD45RA-CCR7+\], CM CD8+ T-cell \[CD45RA-CCR7+\], Effector CD4+ T-cell \[CD45RA+CCR7-\], Effector CD8+ T-cell \[CD45RA+CCR7-\], Effector Memory (EM) CD4+ T-cell \[CD45RA-CCR7-\], EM CD8+ T-cell \[CD45RA-CCR7-\], Effector Regulatory T-cells, Effector CD4+ T-cell \[CD45RA+CCR7-\], Effector CD8+ T-cell \[CD45RA+CCR7-\], Naïve CD4+ T-cell \[CD45RA+\], Naïve CD8+ T-cell \[CD45RA+\], Naïve (N) CD8+ T-cell \[CD45RA+\], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Baseline
|
632.6 cells/mm^3
Standard Deviation 305.86
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 4
|
15.2 cells/mm^3
Standard Deviation 241.73
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 8
|
-26.5 cells/mm^3
Standard Deviation 241.47
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 12
|
-53.4 cells/mm^3
Standard Deviation 246.22
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 24
|
-100.4 cells/mm^3
Standard Deviation 263.58
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 36
|
-106.8 cells/mm^3
Standard Deviation 308.03
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+]: Change at Week 48
|
-125.9 cells/mm^3
Standard Deviation 273.26
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell ([CD38+HLA-DR+]): Baseline
|
22.9 cells/mm^3
Standard Deviation 25.64
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 4
|
3.9 cells/mm^3
Standard Deviation 21.83
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 8
|
-2.2 cells/mm^3
Standard Deviation 24.46
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 12
|
-3.4 cells/mm^3
Standard Deviation 23.53
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 24
|
-5.8 cells/mm^3
Standard Deviation 24.72
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 36
|
-7.9 cells/mm^3
Standard Deviation 27.32
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 48
|
-7.7 cells/mm^3
Standard Deviation 24.92
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Baseline
|
275.4 cells/mm^3
Standard Deviation 158.04
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 4
|
18.2 cells/mm^3
Standard Deviation 118.67
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 8
|
-21.7 cells/mm^3
Standard Deviation 126.38
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 12
|
-50.8 cells/mm^3
Standard Deviation 132.08
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 24
|
-91.8 cells/mm^3
Standard Deviation 142.99
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 36
|
-99.3 cells/mm^3
Standard Deviation 162.79
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 24
|
-82.4 cells/mm^3
Standard Deviation 134.00
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 36
|
-106.1 cells/mm^3
Standard Deviation 139.47
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 48
|
-103.4 cells/mm^3
Standard Deviation 138.84
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Baseline
|
15.8 cells/mm^3
Standard Deviation 13.44
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 4
|
-0.1 cells/mm^3
Standard Deviation 11.90
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 8
|
-0.4 cells/mm^3
Standard Deviation 12.19
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 12
|
-0.7 cells/mm^3
Standard Deviation 9.84
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 24
|
-0.4 cells/mm^3
Standard Deviation 11.87
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 36
|
0.1 cells/mm^3
Standard Deviation 12.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve Regulatory T-cells: Change at Week 48
|
-0.1 cells/mm^3
Standard Deviation 10.25
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Baseline
|
71.5 cells/mm^3
Standard Deviation 36.60
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 4
|
1.0 cells/mm^3
Standard Deviation 34.31
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 8
|
-7.3 cells/mm^3
Standard Deviation 35.01
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 12
|
0.0 cells/mm^3
Standard Deviation 1.36
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 24
|
-0.4 cells/mm^3
Standard Deviation 1.33
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 36
|
-0.4 cells/mm^3
Standard Deviation 0.96
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 48
|
-0.3 cells/mm^3
Standard Deviation 1.06
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: Baseline
|
4.8 cells/mm^3
Standard Deviation 4.83
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: Change at Week 4
|
1.2 cells/mm^3
Standard Deviation 5.36
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: Change at Week 8
|
0.4 cells/mm^3
Standard Deviation 6.13
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: CW 12
|
0.5 cells/mm^3
Standard Deviation 6.54
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: CW 24
|
0.6 cells/mm^3
Standard Deviation 6.84
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: CW 36
|
0.3 cells/mm^3
Standard Deviation 6.57
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th2-enriched phenotype: CW 48
|
0.2 cells/mm^3
Standard Deviation 5.14
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [CD38+HLA-DR+]: Baseline
|
17.3 cells/mm^3
Standard Deviation 12.77
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 4
|
2.5 cells/mm^3
Standard Deviation 11.63
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 8
|
-0.3 cells/mm^3
Standard Deviation 12.81
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 12
|
-1.6 cells/mm^3
Standard Deviation 12.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 24
|
-3.2 cells/mm^3
Standard Deviation 13.54
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 36
|
-4.1 cells/mm^3
Standard Deviation 12.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 48
|
-4.2 cells/mm^3
Standard Deviation 11.62
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Baseline
|
64.6 cells/mm^3
Standard Deviation 32.45
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 4
|
1.4 cells/mm^3
Standard Deviation 27.95
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 8
|
-5.1 cells/mm^3
Standard Deviation 38.57
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 12
|
-11.7 cells/mm^3
Standard Deviation 31.71
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 24
|
-26.0 cells/mm^3
Standard Deviation 30.09
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 36
|
-33.6 cells/mm^3
Standard Deviation 36.39
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD4+ T-cell [HLA-DR+]: Change at Week 48
|
-30.1 cells/mm^3
Standard Deviation 38.57
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Baseline
|
81.2 cells/mm^3
Standard Deviation 63.34
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 4
|
2.5 cells/mm^3
Standard Deviation 46.91
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 8
|
-5.5 cells/mm^3
Standard Deviation 67.56
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 12
|
-18.2 cells/mm^3
Standard Deviation 59.58
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 24
|
-38.1 cells/mm^3
Standard Deviation 57.42
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 36
|
-48.3 cells/mm^3
Standard Deviation 63.85
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [HLA-DR+]: Change at Week 48
|
-49.3 cells/mm^3
Standard Deviation 59.85
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+ T-cell [CD45RA-CCR7+]: Baseline
|
433.4 cells/mm^3
Standard Deviation 220.05
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+ T-cell[CD45RA-CCR7+]:CW 4
|
-21.0 cells/mm^3
Standard Deviation 185.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+ T-cell[CD45RA-CCR7+]:CW 8
|
-68.0 cells/mm^3
Standard Deviation 196.02
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+T-cell[CD45RA-CCR7+]:CW 12
|
-105.3 cells/mm^3
Standard Deviation 206.11
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+T-cell[CD45RA-CCR7+]:CW 24
|
-204.2 cells/mm^3
Standard Deviation 220.61
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CentralMemoryCD4+T-cell[CD45RA-CCR7+]:CW 36
|
-235.7 cells/mm^3
Standard Deviation 221.44
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD4+T-cell[CD45RA-CCR7+]:CW 48
|
-231.1 cells/mm^3
Standard Deviation 225.25
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+ T-cell [CD45RA-CCR7+]: Baseline
|
59.9 cells/mm^3
Standard Deviation 60.38
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 4
|
-9.6 cells/mm^3
Standard Deviation 45.92
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 8
|
-16.9 cells/mm^3
Standard Deviation 41.72
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 12
|
-22.0 cells/mm^3
Standard Deviation 48.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 24
|
-39.2 cells/mm^3
Standard Deviation 50.00
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 36
|
-44.3 cells/mm^3
Standard Deviation 55.66
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
CM CD8+T-cell[CD45RA-CCR7+]:CW 48
|
-45.9 cells/mm^3
Standard Deviation 53.78
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell [CD45RA+CCR7-]: Baseline
|
12.0 cells/mm^3
Standard Deviation 23.21
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek4
|
0.8 cells/mm^3
Standard Deviation 12.66
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek8
|
-0.1 cells/mm^3
Standard Deviation 12.58
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek12
|
-1.0 cells/mm^3
Standard Deviation 12.43
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 24
|
-1.6 cells/mm^3
Standard Deviation 17.42
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 36
|
-1.9 cells/mm^3
Standard Deviation 19.20
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 48
|
-4.7 cells/mm^3
Standard Deviation 18.75
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell [CD45RA+CCR7-]: Baseline
|
101.4 cells/mm^3
Standard Deviation 91.95
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek4
|
1.7 cells/mm^3
Standard Deviation 63.49
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek8
|
-15.9 cells/mm^3
Standard Deviation 67.93
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 12
|
-15.2 cells/mm^3
Standard Deviation 80.78
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 24
|
-42.8 cells/mm^3
Standard Deviation 74.14
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 36
|
-55.6 cells/mm^3
Standard Deviation 78.88
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 48
|
-50.9 cells/mm^3
Standard Deviation 82.46
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Baseline
|
179.7 cells/mm^3
Standard Deviation 86.21
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 4
|
10.9 cells/mm^3
Standard Deviation 87.56
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 8
|
-33.2 cells/mm^3
Standard Deviation 88.53
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 12
|
-55.2 cells/mm^3
Standard Deviation 90.59
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 24
|
-81.7 cells/mm^3
Standard Deviation 106.78
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 36
|
-98.1 cells/mm^3
Standard Deviation 111.77
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 48
|
-118.5 cells/mm^3
Standard Deviation 100.25
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Baseline
|
129.0 cells/mm^3
Standard Deviation 92.24
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 4
|
7.6 cells/mm^3
Standard Deviation 82.42
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 8
|
-22.8 cells/mm^3
Standard Deviation 88.05
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 12
|
-41.0 cells/mm^3
Standard Deviation 85.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 24
|
-69.9 cells/mm^3
Standard Deviation 90.17
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 36
|
-80.3 cells/mm^3
Standard Deviation 96.19
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 48
|
-90.3 cells/mm^3
Standard Deviation 97.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Baseline
|
56.1 cells/mm^3
Standard Deviation 28.88
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 4
|
0.6 cells/mm^3
Standard Deviation 26.13
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 8
|
-7.1 cells/mm^3
Standard Deviation 27.32
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 12
|
-12.7 cells/mm^3
Standard Deviation 25.81
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 24
|
-20.3 cells/mm^3
Standard Deviation 28.31
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 36
|
-25.8 cells/mm^3
Standard Deviation 31.50
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Effector Regulatory T-cells: Change at Week 48
|
-25.1 cells/mm^3
Standard Deviation 29.73
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Baseline
|
617.7 cells/mm^3
Standard Deviation 256.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 4
|
-6.2 cells/mm^3
Standard Deviation 233.54
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 8
|
-100.9 cells/mm^3
Standard Deviation 252.99
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 12
|
-157.7 cells/mm^3
Standard Deviation 269.36
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 24
|
-287.7 cells/mm^3
Standard Deviation 291.97
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 36
|
-335.0 cells/mm^3
Standard Deviation 299.23
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD4+ T-cell [CD45RA-]: Change at Week 48
|
-349.9 cells/mm^3
Standard Deviation 289.24
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Baseline
|
187.5 cells/mm^3
Standard Deviation 126.58
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 4
|
-4.7 cells/mm^3
Standard Deviation 97.59
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 8
|
-40.9 cells/mm^3
Standard Deviation 109.49
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 12
|
-64.0 cells/mm^3
Standard Deviation 118.89
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 24
|
-108.6 cells/mm^3
Standard Deviation 119.94
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 36
|
-124.9 cells/mm^3
Standard Deviation 126.30
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Memory CD8+ T-cell [CD45RA-]: Change at Week 48
|
-136.3 cells/mm^3
Standard Deviation 129.68
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+CCR7+]: Baseline
|
400.9 cells/mm^3
Standard Deviation 261.16
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 4
|
-10.5 cells/mm^3
Standard Deviation 175.86
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 8
|
-16.4 cells/mm^3
Standard Deviation 169.60
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 12
|
-11.8 cells/mm^3
Standard Deviation 177.35
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 24
|
-31.7 cells/mm^3
Standard Deviation 190.17
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 36
|
-29.3 cells/mm^3
Standard Deviation 204.15
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 48
|
-34.4 cells/mm^3
Standard Deviation 197.57
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Baseline
|
416.7 cells/mm^3
Standard Deviation 268.35
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 4
|
-8.6 cells/mm^3
Standard Deviation 177.59
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 8
|
-15.6 cells/mm^3
Standard Deviation 173.25
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 12
|
-10.2 cells/mm^3
Standard Deviation 185.67
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 24
|
-33.6 cells/mm^3
Standard Deviation 193.78
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 36
|
-30.2 cells/mm^3
Standard Deviation 214.46
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD4+ T-cell [CD45RA+]: Change at Week 48
|
-37.0 cells/mm^3
Standard Deviation 206.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+CCR7+]: Baseline
|
160.1 cells/mm^3
Standard Deviation 108.32
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 4
|
-11.6 cells/mm^3
Standard Deviation 79.05
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 8
|
-12.4 cells/mm^3
Standard Deviation 75.66
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 12
|
-22.0 cells/mm^3
Standard Deviation 73.23
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 24
|
-41.3 cells/mm^3
Standard Deviation 77.22
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 36
|
-49.0 cells/mm^3
Standard Deviation 88.78
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 48
|
-50.9 cells/mm^3
Standard Deviation 80.43
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Baseline
|
258.0 cells/mm^3
Standard Deviation 150.73
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 4
|
-11.7 cells/mm^3
Standard Deviation 118.68
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 8
|
-28.3 cells/mm^3
Standard Deviation 118.33
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Naïve CD8+ T-cell [CD45RA+]: Change at Week 12
|
-39.7 cells/mm^3
Standard Deviation 131.27
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated CD8+ T-cell [CD38+]: Change at Week 48
|
-114.3 cells/mm^3
Standard Deviation 152.39
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Baseline
|
10.4 cells/mm^3
Standard Deviation 6.52
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 4
|
0.6 cells/mm^3
Standard Deviation 6.09
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 8
|
-1.2 cells/mm^3
Standard Deviation 6.87
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 12
|
-2.1 cells/mm^3
Standard Deviation 6.63
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 24
|
-3.5 cells/mm^3
Standard Deviation 6.47
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 36
|
-3.8 cells/mm^3
Standard Deviation 6.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th1 phenotype: Change at Week 48
|
-4.0 cells/mm^3
Standard Deviation 6.50
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Baseline
|
1.1 cells/mm^3
Standard Deviation 1.33
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 4
|
0.0 cells/mm^3
Standard Deviation 1.01
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Activated Th17 phenotype: Change at Week 8
|
-0.2 cells/mm^3
Standard Deviation 1.50
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 12
|
-13.3 cells/mm^3
Standard Deviation 32.12
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 24
|
-20.0 cells/mm^3
Standard Deviation 36.77
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 36
|
-25.7 cells/mm^3
Standard Deviation 40.18
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Regulatory T-cells: Change at Week 48
|
-24.4 cells/mm^3
Standard Deviation 36.09
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: Baseline
|
327.2 cells/mm^3
Standard Deviation 168.48
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 4
|
16.6 cells/mm^3
Standard Deviation 158.45
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 8
|
-4.4 cells/mm^3
Standard Deviation 167.36
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 12
|
-17.6 cells/mm^3
Standard Deviation 167.80
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 24
|
-58.3 cells/mm^3
Standard Deviation 174.97
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 36
|
-97.2 cells/mm^3
Standard Deviation 199.08
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Terminal Effector Regulatory T-cells: CW 48
|
-98.6 cells/mm^3
Standard Deviation 186.01
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Baseline
|
329.5 cells/mm^3
Standard Deviation 153.17
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 4
|
-14.7 cells/mm^3
Standard Deviation 127.21
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 8
|
-65.4 cells/mm^3
Standard Deviation 147.25
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 12
|
-102.1 cells/mm^3
Standard Deviation 149.63
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 24
|
-159.2 cells/mm^3
Standard Deviation 172.24
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 36
|
-183.0 cells/mm^3
Standard Deviation 177.40
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th1 phenotype: Change at Week 48
|
-187.4 cells/mm^3
Standard Deviation 172.19
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Baseline
|
61.9 cells/mm^3
Standard Deviation 40.76
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 4
|
-0.5 cells/mm^3
Standard Deviation 37.46
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 8
|
-7.3 cells/mm^3
Standard Deviation 39.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 12
|
-1.1 cells/mm^3
Standard Deviation 45.74
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 24
|
-24.6 cells/mm^3
Standard Deviation 42.79
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 36
|
-35.1 cells/mm^3
Standard Deviation 39.56
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th17 phenotype: Change at Week 48
|
-30.1 cells/mm^3
Standard Deviation 39.12
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Baseline
|
562.7 cells/mm^3
Standard Deviation 289.42
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 4
|
-0.6 cells/mm^3
Standard Deviation 211.18
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 8
|
-31.5 cells/mm^3
Standard Deviation 227.69
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 12
|
-54.0 cells/mm^3
Standard Deviation 210.95
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 24
|
-96.7 cells/mm^3
Standard Deviation 241.83
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 36
|
-97.7 cells/mm^3
Standard Deviation 267.45
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Th2-enriched phenotype: Change at Week 48
|
-125.2 cells/mm^3
Standard Deviation 242.46
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells \[non-class switched\], IgD- Memory B cells \[class switched\], Naïve B cells, Plasma Cells \[CD10-\], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Baseline
|
9.4 cells/mm^3
Standard Deviation 9.93
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 4
|
-1.2 cells/mm^3
Standard Deviation 7.98
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 8
|
-0.4 cells/mm^3
Standard Deviation 8.73
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 12
|
-0.4 cells/mm^3
Standard Deviation 9.09
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 24
|
3.6 cells/mm^3
Standard Deviation 10.16
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 36
|
2.8 cells/mm^3
Standard Deviation 9.53
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD10+ Transitional B cells: Change at Week 48
|
5.7 cells/mm^3
Standard Deviation 13.53
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Baseline
|
0.26 cells/mm^3
Standard Deviation 0.289
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 4
|
-0.02 cells/mm^3
Standard Deviation 0.367
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 8
|
-0.12 cells/mm^3
Standard Deviation 0.291
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 12
|
-0.15 cells/mm^3
Standard Deviation 0.288
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 24
|
-0.21 cells/mm^3
Standard Deviation 0.297
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 36
|
-0.21 cells/mm^3
Standard Deviation 0.327
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
CD138+ Plasma Cells: Change at Week 48
|
-0.19 cells/mm^3
Standard Deviation 0.318
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells [non-class switched]: Baseline
|
37.8 cells/mm^3
Standard Deviation 36.96
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells[non-class switched]: CW 4
|
-8.9 cells/mm^3
Standard Deviation 26.18
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells[non-class switched]: CW 8
|
-12.4 cells/mm^3
Standard Deviation 29.27
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells[non-class switched]: CW 12
|
-12.1 cells/mm^3
Standard Deviation 29.13
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells[non-class switched]: CW 24
|
-17.6 cells/mm^3
Standard Deviation 31.39
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells[non-class switched]: CW 36
|
-19.6 cells/mm^3
Standard Deviation 31.61
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD+ Memory B cells [non-class switched]: CW 48
|
-13.4 cells/mm^3
Standard Deviation 34.89
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: Baseline
|
50.4 cells/mm^3
Standard Deviation 56.97
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 4
|
-8.7 cells/mm^3
Standard Deviation 32.20
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 8
|
-17.7 cells/mm^3
Standard Deviation 44.42
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 12
|
-23.1 cells/mm^3
Standard Deviation 44.76
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 24
|
-29.5 cells/mm^3
Standard Deviation 49.95
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 36
|
49.95 cells/mm^3
Standard Deviation 32.64
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
IgD- Memory B cells [class switched]: CW 48
|
-27.4 cells/mm^3
Standard Deviation 38.33
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Baseline
|
197.2 cells/mm^3
Standard Deviation 140.48
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 4
|
-21.5 cells/mm^3
Standard Deviation 82.43
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 8
|
-37.2 cells/mm^3
Standard Deviation 95.32
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 12
|
-43.1 cells/mm^3
Standard Deviation 99.72
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 24
|
-45.7 cells/mm^3
Standard Deviation 114.46
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 36
|
-54.0 cells/mm^3
Standard Deviation 94.94
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Naïve B cells: Change at Week 48
|
-35.6 cells/mm^3
Standard Deviation 107.79
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Baseline
|
0.63 cells/mm^3
Standard Deviation 0.668
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 4
|
-0.02 cells/mm^3
Standard Deviation 0.816
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 8
|
-0.11 cells/mm^3
Standard Deviation 0.643
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 12
|
-0.18 cells/mm^3
Standard Deviation 0.647
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 24
|
-0.34 cells/mm^3
Standard Deviation 0.649
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 36
|
-0.33 cells/mm^3
Standard Deviation 0.786
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasma Cells [CD10-]: Change at Week 48
|
-0.38 cells/mm^3
Standard Deviation 0.633
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Baseline
|
13.6 cells/mm^3
Standard Deviation 13.61
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 4
|
-1.3 cells/mm^3
Standard Deviation 11.44
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 8
|
0.6 cells/mm^3
Standard Deviation 12.97
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 12
|
0.7 cells/mm^3
Standard Deviation 13.41
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 24
|
5.8 cells/mm^3
Standard Deviation 15.60
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 36
|
4.2 cells/mm^3
Standard Deviation 13.20
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Transitional B-cells: Change at Week 48
|
7.3 cells/mm^3
Standard Deviation 18.56
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Baseline
|
0.91 cells/mm^3
Standard Deviation 1.104
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 4
|
-0.04 cells/mm^3
Standard Deviation 1.120
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 8
|
-0.21 cells/mm^3
Standard Deviation 1.062
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 12
|
-0.31 cells/mm^3
Standard Deviation 1.024
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 24
|
-0.46 cells/mm^3
Standard Deviation 1.106
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 36
|
-0.46 cells/mm^3
Standard Deviation 1.228
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Plasmablasts: Change at Week 48
|
-0.50 cells/mm^3
Standard Deviation 1.084
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes \[CD14+\].
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Baseline
|
14.0 cells/mm^3
Standard Deviation 8.94
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 4
|
1.8 cells/mm^3
Standard Deviation 6.40
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 8
|
1.8 cells/mm^3
Standard Deviation 7.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 12
|
1.3 cells/mm^3
Standard Deviation 7.26
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 24
|
2.1 cells/mm^3
Standard Deviation 8.57
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 36
|
2.3 cells/mm^3
Standard Deviation 9.73
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Bright NK cells: Change at Week 48
|
2.1 cells/mm^3
Standard Deviation 8.55
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Baseline
|
192.9 cells/mm^3
Standard Deviation 130.45
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 4
|
-2.0 cells/mm^3
Standard Deviation 102.59
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 8
|
-17.2 cells/mm^3
Standard Deviation 102.92
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 12
|
-31.4 cells/mm^3
Standard Deviation 92.14
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 24
|
-50.7 cells/mm^3
Standard Deviation 101.34
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 36
|
-61.1 cells/mm^3
Standard Deviation 102.96
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
CD56Dim NK cells: Change at Week 48
|
-68.5 cells/mm^3
Standard Deviation 129.83
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Baseline
|
301.4 cells/mm^3
Standard Deviation 153.48
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 4
|
7.5 cells/mm^3
Standard Deviation 182.11
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 8
|
6.0 cells/mm^3
Standard Deviation 165.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 12
|
9.3 cells/mm^3
Standard Deviation 197.84
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 24
|
-8.7 cells/mm^3
Standard Deviation 151.23
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 36
|
-1.5 cells/mm^3
Standard Deviation 163.62
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Classical Monocytes: Change at Week 48
|
-0.8 cells/mm^3
Standard Deviation 153.24
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Baseline
|
24.96 cells/mm^3
Standard Deviation 16.315
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 4
|
1.46 cells/mm^3
Standard Deviation 18.111
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 8
|
-0.61 cells/mm^3
Standard Deviation 17.670
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 12
|
-0.23 cells/mm^3
Standard Deviation 17.932
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 24
|
3.02 cells/mm^3
Standard Deviation 17.882
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 36
|
3.63 cells/mm^3
Standard Deviation 18.779
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Myeloid dendritic cells: Change at Week 48
|
-6.20 cells/mm^3
Standard Deviation 17.780
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Baseline
|
32.0 cells/mm^3
Standard Deviation 22.88
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 4
|
2.2 cells/mm^3
Standard Deviation 29.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 8
|
-1.9 cells/mm^3
Standard Deviation 30.14
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 12
|
-10.8 cells/mm^3
Standard Deviation 23.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 24
|
-6.9 cells/mm^3
Standard Deviation 27.65
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 36
|
-10.6 cells/mm^3
Standard Deviation 24.24
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Non-classical Monocytes: Change at Week 48
|
-9.2 cells/mm^3
Standard Deviation 24.37
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Baseline
|
6.52 cells/mm^3
Standard Deviation 4.617
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 4
|
0.00 cells/mm^3
Standard Deviation 5.168
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 8
|
0.30 cells/mm^3
Standard Deviation 6.427
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 12
|
-0.86 cells/mm^3
Standard Deviation 4.575
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 24
|
-0.69 cells/mm^3
Standard Deviation 4.138
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 36
|
-0.80 cells/mm^3
Standard Deviation 4.086
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Plasmacytoid dendritic cells: Change at Week 48
|
-2.22 cells/mm^3
Standard Deviation 4.509
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Baseline
|
35.4 cells/mm^3
Standard Deviation 19.92
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 4
|
2.0 cells/mm^3
Standard Deviation 22.35
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 8
|
-1.3 cells/mm^3
Standard Deviation 21.68
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 12
|
-1.9 cells/mm^3
Standard Deviation 21.07
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 24
|
1.6 cells/mm^3
Standard Deviation 21.89
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 36
|
2.5 cells/mm^3
Standard Deviation 22.19
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total dendritic cells: Change at Week 48
|
-9.1 cells/mm^3
Standard Deviation 22.77
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 4
|
26.9 cells/mm^3
Standard Deviation 201.63
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 8
|
12.6 cells/mm^3
Standard Deviation 189.91
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 12
|
14.4 cells/mm^3
Standard Deviation 211.67
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 24
|
-19.3 cells/mm^3
Standard Deviation 174.82
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 36
|
-21.7 cells/mm^3
Standard Deviation 186.41
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Change at Week 48
|
-19.2 cells/mm^3
Standard Deviation 175.10
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Total monocytes [CD14+]: Baseline
|
374.6 cells/mm^3
Standard Deviation 179.05
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Baseline
|
3.340 cells/mm^3
Standard Deviation 2.7365
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week 4
|
0.090 cells/mm^3
Standard Deviation 2.2350
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week 8
|
-0.356 cells/mm^3
Standard Deviation 1.9676
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week12
|
-0.729 cells/mm^3
Standard Deviation 2.1570
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week24
|
-1.134 cells/mm^3
Standard Deviation 2.4239
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week36
|
-1.511 cells/mm^3
Standard Deviation 2.5109
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD4+ T cells): Change at Week48
|
-1.222 cells/mm^3
Standard Deviation 2.3513
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Baseline
|
6.166 cells/mm^3
Standard Deviation 4.6199
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week 4
|
0.493 cells/mm^3
Standard Deviation 2.8636
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week 8
|
-0.264 cells/mm^3
Standard Deviation 3.0735
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week12
|
-1.345 cells/mm^3
Standard Deviation 3.3647
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week24
|
-1.650 cells/mm^3
Standard Deviation 2.7202
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week36
|
-1.922 cells/mm^3
Standard Deviation 4.1425
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of CD8+ T cells): Change at Week48
|
-1.306 cells/mm^3
Standard Deviation 4.3931
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): Baseline
|
4.518 cells/mm^3
Standard Deviation 3.0417
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 4
|
0.050 cells/mm^3
Standard Deviation 2.5996
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 8
|
-0.295 cells/mm^3
Standard Deviation 2.6287
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 12
|
-0.851 cells/mm^3
Standard Deviation 2.8590
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 24
|
-1.019 cells/mm^3
Standard Deviation 2.8120
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 36
|
-1.804 cells/mm^3
Standard Deviation 2.6448
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD4+ T cells): CW 48
|
-1.369 cells/mm^3
Standard Deviation 3.0958
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): Baseline
|
8.795 cells/mm^3
Standard Deviation 5.9060
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 4
|
0.360 cells/mm^3
Standard Deviation 3.6006
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 8
|
-0.285 cells/mm^3
Standard Deviation 4.2645
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 12
|
-1.543 cells/mm^3
Standard Deviation 3.7393
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 24
|
-0.964 cells/mm^3
Standard Deviation 3.6799
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 36
|
-2.035 cells/mm^3
Standard Deviation 5.3349
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IFNg+ (% of memory CD8+ T cells): CW 48
|
-0.497 cells/mm^3
Standard Deviation 5.3126
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells): Baseline
|
1.244 cells/mm^3
Standard Deviation 1.5863
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week4
|
0.115 cells/mm^3
Standard Deviation 1.9918
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week8
|
0.131 cells/mm^3
Standard Deviation 1.9097
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week12
|
0.470 cells/mm^3
Standard Deviation 2.3445
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week24
|
0.165 cells/mm^3
Standard Deviation 2.0104
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week36
|
0.419 cells/mm^3
Standard Deviation 2.5007
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week48
|
1.693 cells/mm^3
Standard Deviation 4.2412
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells): Baseline
|
0.455 cells/mm^3
Standard Deviation 0.5309
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week4
|
0.239 cells/mm^3
Standard Deviation 1.3557
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week8
|
0.032 cells/mm^3
Standard Deviation 0.6448
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week12
|
0.301 cells/mm^3
Standard Deviation 0.8912
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week24
|
0.289 cells/mm^3
Standard Deviation 0.8526
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week36
|
0.911 cells/mm^3
Standard Deviation 1.3499
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week48
|
1.457 cells/mm^3
Standard Deviation 2.1499
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+ T cells): Baseline
|
1.075 cells/mm^3
Standard Deviation 1.1770
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 4
|
0.000 cells/mm^3
Standard Deviation 1.3599
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 8
|
0.040 cells/mm^3
Standard Deviation 1.3593
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 12
|
0.373 cells/mm^3
Standard Deviation 1.7166
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 24
|
0.228 cells/mm^3
Standard Deviation 1.4980
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 36
|
0.333 cells/mm^3
Standard Deviation 1.8786
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD4+T cells): CW 48
|
1.255 cells/mm^3
Standard Deviation 2.9557
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+ T cells): Baseline
|
0.155 cells/mm^3
Standard Deviation 0.2356
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 4
|
0.113 cells/mm^3
Standard Deviation 0.6972
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 8
|
0.027 cells/mm^3
Standard Deviation 0.3641
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 12
|
0.064 cells/mm^3
Standard Deviation 0.3641
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 24
|
0.254 cells/mm^3
Standard Deviation 0.8682
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 36
|
0.270 cells/mm^3
Standard Deviation 0.6113
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-17A+/IFNg- (% of memory CD8+T cells): CW 48
|
0.680 cells/mm^3
Standard Deviation 1.2842
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Baseline
|
5.177 cells/mm^3
Standard Deviation 4.5225
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 4
|
0.062 cells/mm^3
Standard Deviation 3.4662
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 8
|
0.149 cells/mm^3
Standard Deviation 4.0713
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 12
|
-0.069 cells/mm^3
Standard Deviation 4.0822
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 24
|
-0.448 cells/mm^3
Standard Deviation 3.6280
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 36
|
-1.837 cells/mm^3
Standard Deviation 3.8603
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD4+ T cells): Change at Week 48
|
-1.840 cells/mm^3
Standard Deviation 5.0951
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Baseline
|
1.180 cells/mm^3
Standard Deviation 1.4533
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 4
|
-0.081 cells/mm^3
Standard Deviation 1.2797
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 8
|
-0.227 cells/mm^3
Standard Deviation 1.1579
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 12
|
-0.2622 cells/mm^3
Standard Deviation 1.2601
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 24
|
-0.525 cells/mm^3
Standard Deviation 1.0201
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 36
|
-0.547 cells/mm^3
Standard Deviation 1.2886
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of CD8+ T cells): Change at Week 48
|
-0.248 cells/mm^3
Standard Deviation 1.1860
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Baseline
|
7.053 cells/mm^3
Standard Deviation 5.6653
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week 4
|
-0.105 cells/mm^3
Standard Deviation 4.4131
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week 8
|
0.056 cells/mm^3
Standard Deviation 4.6541
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week12
|
0.012 cells/mm^3
Standard Deviation 4.9241
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week24
|
0.015 cells/mm^3
Standard Deviation 4.6456
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week36
|
-2.140 cells/mm^3
Standard Deviation 4.7723
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD4+ T cells): Change at Week48
|
-1.946 cells/mm^3
Standard Deviation 5.6985
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Baseline
|
1.879 cells/mm^3
Standard Deviation 1.7964
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week 4
|
-0.218 cells/mm^3
Standard Deviation 1.6838
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week 8
|
-0.318 cells/mm^3
Standard Deviation 1.7272
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week12
|
-0.115 cells/mm^3
Standard Deviation 1.7354
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week24
|
-0.461 cells/mm^3
Standard Deviation 1.4512
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week36
|
-0.803 cells/mm^3
Standard Deviation 1.8525
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-2+ (% of memory CD8+ T cells): Change at Week48
|
-0.315 cells/mm^3
Standard Deviation 2.0510
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells: Baseline
|
1.261 cells/mm^3
Standard Deviation 1.1190
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week 4
|
-0.150 cells/mm^3
Standard Deviation 1.0429
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week 8
|
-0.113 cells/mm^3
Standard Deviation 1.2168
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week12
|
-0.370 cells/mm^3
Standard Deviation 1.0594
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week24
|
-0.170 cells/mm^3
Standard Deviation 1.1551
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week36
|
-0.376 cells/mm^3
Standard Deviation 1.0920
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD4+ T cells): Change at Week48
|
0.281 cells/mm^3
Standard Deviation 4.7206
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Baseline
|
1.107 cells/mm^3
Standard Deviation 1.2924
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week 4
|
-0.222 cells/mm^3
Standard Deviation 1.2163
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week 8
|
-0.189 cells/mm^3
Standard Deviation 1.3377
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week12
|
-0.553 cells/mm^3
Standard Deviation 1.3754
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week24
|
-0.032 cells/mm^3
Standard Deviation 1.3170
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week36
|
-0.195 cells/mm^3
Standard Deviation 1.3334
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of CD8+ T cells): Change at Week48
|
0.786 cells/mm^3
Standard Deviation 1.3454
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Baseline
|
1.406 cells/mm^3
Standard Deviation 1.2437
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week 4
|
-0.128 cells/mm^3
Standard Deviation 1.2649
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week 8
|
-0.141 cells/mm^3
Standard Deviation 1.4642
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week12
|
-0.412 cells/mm^3
Standard Deviation 1.3656
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week24
|
-0.136 cells/mm^3
Standard Deviation 1.3059
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week36
|
-0.266 cells/mm^3
Standard Deviation 1.4005
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD4+ T cells): Change at Week48
|
0.325 cells/mm^3
Standard Deviation 1.7918
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Baseline
|
1.376 cells/mm^3
Standard Deviation 1.8963
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week 4
|
-0.180 cells/mm^3
Standard Deviation 2.0821
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week 8
|
-0.269 cells/mm^3
Standard Deviation 1.9840
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week12
|
-0.795 cells/mm^3
Standard Deviation 2.2486
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week24
|
0.416 cells/mm^3
Standard Deviation 2.3613
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week36
|
-0.284 cells/mm^3
Standard Deviation 2.4433
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
IL-4+ (% of memory CD8+ T cells): Change at Week48
|
1.836 cells/mm^3
Standard Deviation 2.7709
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.
VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells \[CD11c++\]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells \[CD11c++\]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Baseline
|
99.33 cells/mm^3
Standard Deviation 2.106
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 4
|
0.34 cells/mm^3
Standard Deviation 2.497
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 8
|
0.44 cells/mm^3
Standard Deviation 2.203
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 12
|
0.17 cells/mm^3
Standard Deviation 2.534
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 24
|
0.19 cells/mm^3
Standard Deviation 2.549
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 36
|
-1.43 cells/mm^3
Standard Deviation 11.406
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of B cells): Change at Week 48
|
-0.14 cells/mm^3
Standard Deviation 7.751
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Baseline
|
99.90 cells/mm^3
Standard Deviation 0.312
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 4
|
0.05 cells/mm^3
Standard Deviation 0.319
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 8
|
0.07 cells/mm^3
Standard Deviation 0.327
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 12
|
0.06 cells/mm^3
Standard Deviation 0.321
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 24
|
0.02 cells/mm^3
Standard Deviation 0.633
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 36
|
-1.29 cells/mm^3
Standard Deviation 9.760
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of T cells): Change at Week 48
|
-0.53 cells/mm^3
Standard Deviation 7.410
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Baseline
|
96.85 cells/mm^3
Standard Deviation 3.089
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 4
|
0.47 cells/mm^3
Standard Deviation 3.630
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 8
|
0.59 cells/mm^3
Standard Deviation 3.532
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 12
|
0.59 cells/mm^3
Standard Deviation 3.710
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 24
|
-0.38 cells/mm^3
Standard Deviation 3.963
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 36
|
-1.55 cells/mm^3
Standard Deviation 10.918
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of MNC): Change at Week 48
|
-2.31 cells/mm^3
Standard Deviation 8.402
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): Baseline
|
99.81 cells/mm^3
Standard Deviation 0.933
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 4
|
0.04 cells/mm^3
Standard Deviation 0.867
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 8
|
0.02 cells/mm^3
Standard Deviation 1.573
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 12
|
0.10 cells/mm^3
Standard Deviation 1.250
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 24
|
0.01 cells/mm^3
Standard Deviation 1.477
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 36
|
-1.27 cells/mm^3
Standard Deviation 10.857
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of dendritic cells [CD11c++]): CW 48
|
-0.84 cells/mm^3
Standard Deviation 7.813
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Baseline
|
98.24 cells/mm^3
Standard Deviation 1.870
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 4
|
0.04 cells/mm^3
Standard Deviation 2.227
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 8
|
0.07 cells/mm^3
Standard Deviation 2.649
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 12
|
0.26 cells/mm^3
Standard Deviation 2.604
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 24
|
-0.35 cells/mm^3
Standard Deviation 2.519
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 36
|
-1.99 cells/mm^3
Standard Deviation 10.532
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of lymphocytes): Change at Week 48
|
-2.56 cells/mm^3
Standard Deviation 8.696
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Baseline
|
98.00 cells/mm^3
Standard Deviation 2.303
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 4
|
0.29 cells/mm^3
Standard Deviation 3.241
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 8
|
0.92 cells/mm^3
Standard Deviation 2.416
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 12
|
0.77 cells/mm^3
Standard Deviation 2.539
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 24
|
-0.40 cells/mm^3
Standard Deviation 3.046
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 36
|
-0.36 cells/mm^3
Standard Deviation 7.843
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of monocytes): Change at Week 48
|
-1.52 cells/mm^3
Standard Deviation 7.711
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Baseline
|
97.80 cells/mm^3
Standard Deviation 5.352
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 4
|
0.83 cells/mm^3
Standard Deviation 6.672
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 8
|
1.23 cells/mm^3
Standard Deviation 5.675
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 12
|
0.55 cells/mm^3
Standard Deviation 6.113
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 24
|
0.35 cells/mm^3
Standard Deviation 9.220
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 36
|
-2.88 cells/mm^3
Standard Deviation 18.513
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD11a+ (% of neutrophils): Change at Week 48
|
0.42 cells/mm^3
Standard Deviation 10.736
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Baseline
|
99.87 cells/mm^3
Standard Deviation 0.679
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 4
|
-0.50 cells/mm^3
Standard Deviation 7.105
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 8
|
0.00 cells/mm^3
Standard Deviation 0.642
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 12
|
0.01 cells/mm^3
Standard Deviation 0.486
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 24
|
-0.01 cells/mm^3
Standard Deviation 0.663
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 36
|
-0.07 cells/mm^3
Standard Deviation 0.744
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of B cells): Change at Week 48
|
-0.04 cells/mm^3
Standard Deviation 0.964
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Baseline
|
91.23 cells/mm^3
Standard Deviation 4.427
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 4
|
-0.45 cells/mm^3
Standard Deviation 6.909
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 8
|
-0.11 cells/mm^3
Standard Deviation 2.055
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 12
|
-0.06 cells/mm^3
Standard Deviation 1.930
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 24
|
-0.12 cells/mm^3
Standard Deviation 2.209
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 36
|
-1.32 cells/mm^3
Standard Deviation 4.256
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of T cells): Change at Week 48
|
-0.02 cells/mm^3
Standard Deviation 2.935
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Baseline
|
86.79 cells/mm^3
Standard Deviation 5.369
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 4
|
0.23 cells/mm^3
Standard Deviation 8.274
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 8
|
0.38 cells/mm^3
Standard Deviation 5.600
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 12
|
0.85 cells/mm^3
Standard Deviation 5.900
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 24
|
-0.07 cells/mm^3
Standard Deviation 6.051
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 36
|
-0.46 cells/mm^3
Standard Deviation 8.264
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of MNC): Change at Week 48
|
-1.25 cells/mm^3
Standard Deviation 6.561
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): Baseline
|
99.77 cells/mm^3
Standard Deviation 0.771
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 4
|
-0.42 cells/mm^3
Standard Deviation 7.185
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 8
|
0.12 cells/mm^3
Standard Deviation 0.874
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 12
|
0.03 cells/mm^3
Standard Deviation 1.252
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 24
|
0.00 cells/mm^3
Standard Deviation 1.162
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 36
|
-0.06 cells/mm^3
Standard Deviation 1.532
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of dendritic cells [CD11c++]): CW 48
|
-0.23 cells/mm^3
Standard Deviation 1.530
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Baseline
|
91.29 cells/mm^3
Standard Deviation 4.715
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 4
|
-0.31 cells/mm^3
Standard Deviation 7.260
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 8
|
0.03 cells/mm^3
Standard Deviation 5.899
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 12
|
0.44 cells/mm^3
Standard Deviation 2.989
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 24
|
0.01 cells/mm^3
Standard Deviation 3.237
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 36
|
-0.75 cells/mm^3
Standard Deviation 5.045
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of lymphocytes): Change at Week 48
|
-1.10 cells/mm^3
Standard Deviation 5.739
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Baseline
|
88.77 cells/mm^3
Standard Deviation 8.126
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 4
|
0.82 cells/mm^3
Standard Deviation 10.895
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 8
|
0.96 cells/mm^3
Standard Deviation 10.161
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 12
|
0.82 cells/mm^3
Standard Deviation 10.350
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 24
|
0.98 cells/mm^3
Standard Deviation 9.793
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 36
|
3.87 cells/mm^3
Standard Deviation 9.683
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of monocytes): Change at Week 48
|
0.69 cells/mm^3
Standard Deviation 10.594
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Baseline
|
5.61 cells/mm^3
Standard Deviation 7.277
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 4
|
4.43 cells/mm^3
Standard Deviation 9.345
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 8
|
1.17 cells/mm^3
Standard Deviation 4.892
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 12
|
0.27 cells/mm^3
Standard Deviation 4.137
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 24
|
-0.67 cells/mm^3
Standard Deviation 10.365
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 36
|
-0.29 cells/mm^3
Standard Deviation 12.678
|
|
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
CD49d+ (% of neutrophils): Change at Week 48
|
0.92 cells/mm^3
Standard Deviation 10.291
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Baseline
|
2116.5 milligram per liter (mg/L)
Standard Deviation 910.47
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 4
|
-120.0 milligram per liter (mg/L)
Standard Deviation 231.16
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 8
|
-112.8 milligram per liter (mg/L)
Standard Deviation 243.28
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 12
|
-93.6 milligram per liter (mg/L)
Standard Deviation 291.76
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 24
|
-101.5 milligram per liter (mg/L)
Standard Deviation 324.27
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 36
|
-65.1 milligram per liter (mg/L)
Standard Deviation 279.53
|
|
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Change at Week 48
|
-94.9 milligram per liter (mg/L)
Standard Deviation 291.25
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Baseline
|
1330.1 mg/L
Standard Deviation 705.92
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 4
|
-68.9 mg/L
Standard Deviation 214.07
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 8
|
-23.2 mg/L
Standard Deviation 208.48
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 12
|
-18.8 mg/L
Standard Deviation 270.82
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 24
|
-36.9 mg/L
Standard Deviation 293.14
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 36
|
-19.4 mg/L
Standard Deviation 406.86
|
|
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Change at Week 48
|
-96.8 mg/L
Standard Deviation 236.48
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Baseline
|
10.51 g/L
Standard Deviation 2.328
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 4
|
-0.77 g/L
Standard Deviation 1.039
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 8
|
-0.64 g/L
Standard Deviation 1.077
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 12
|
-0.44 g/L
Standard Deviation 1.187
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 24
|
-0.62 g/L
Standard Deviation 1.324
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 36
|
-0.36 g/L
Standard Deviation 1.025
|
|
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Change at Week 48
|
-0.53 g/L
Standard Deviation 1.142
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48Population: The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.
Outcome measures
| Measure |
Dimethyl Fumarate (BG00012)
n=218 Participants
Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Baseline
|
542.9 milligram per deciliter
Standard Deviation 152.87
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 4
|
-29.2 milligram per deciliter
Standard Deviation 68.22
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 8
|
-28.5 milligram per deciliter
Standard Deviation 71.46
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 12
|
-14.8 milligram per deciliter
Standard Deviation 79.07
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 24
|
-3.0 milligram per deciliter
Standard Deviation 78.80
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 36
|
-23.1 milligram per deciliter
Standard Deviation 61.73
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 1: Change at Week 48
|
-0.5 milligram per deciliter
Standard Deviation 102.41
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Baseline
|
350.7 milligram per deciliter
Standard Deviation 116.43
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 4
|
-22.7 milligram per deciliter
Standard Deviation 47.42
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 8
|
-26.5 milligram per deciliter
Standard Deviation 48.98
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 12
|
-18.9 milligram per deciliter
Standard Deviation 44.11
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 24
|
-5.5 milligram per deciliter
Standard Deviation 54.39
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 36
|
-22.4 milligram per deciliter
Standard Deviation 45.49
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 2: Change at Week 48
|
-21.5 milligram per deciliter
Standard Deviation 50.98
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Baseline
|
56.93 milligram per deciliter
Standard Deviation 26.860
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 4
|
-2.1 milligram per deciliter
Standard Deviation 8.56
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 12
|
-1.0 milligram per deciliter
Standard Deviation 15.48
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 24
|
-0.4 milligram per deciliter
Standard Deviation 11.31
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 36
|
4.6 milligram per deciliter
Standard Deviation 19.09
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 48
|
1.5 milligram per deciliter
Standard Deviation 12.55
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Baseline
|
30.35 milligram per deciliter
Standard Deviation 29.681
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 4
|
1.24 milligram per deciliter
Standard Deviation 9.242
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 8
|
-0.38 milligram per deciliter
Standard Deviation 10.995
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 12
|
-0.12 milligram per deciliter
Standard Deviation 11.711
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 24
|
1.08 milligram per deciliter
Standard Deviation 15.253
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 36
|
1.28 milligram per deciliter
Standard Deviation 12.236
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 4: Change at Week 48
|
3.26 milligram per deciliter
Standard Deviation 10.962
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Baseline
|
1029.9 milligram per deciliter
Standard Deviation 232.33
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 4
|
-54.6 milligram per deciliter
Standard Deviation 101.48
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 8
|
-41.9 milligram per deciliter
Standard Deviation 100.16
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 12
|
-28.5 milligram per deciliter
Standard Deviation 114.30
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 24
|
-55.7 milligram per deciliter
Standard Deviation 116.69
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 36
|
-70.3 milligram per deciliter
Standard Deviation 103.59
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclasses 1-4 Quant: Change at Week 48
|
-65.1 milligram per deciliter
Standard Deviation 130.94
|
|
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
IgG Subclass 3: Change at Week 8
|
-0.7 milligram per deciliter
Standard Deviation 12.36
|
Adverse Events
Dimethyl Fumarate (BG00012)
Serious events: 26 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimethyl Fumarate (BG00012)
n=218 participants at risk
Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Iridocyclitis
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
7.3%
16/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neurological decompensation
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Product Issues
Device malfunction
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.46%
1/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Dimethyl Fumarate (BG00012)
n=218 participants at risk
Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.0%
13/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
11/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
22/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.1%
22/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
28/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.1%
22/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
14/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
12.4%
27/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
15.1%
33/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.8%
28/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.0%
13/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
15/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
14/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
7.3%
16/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
18.8%
41/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.0%
13/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
5.5%
12/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
11/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
17/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Flushing
|
45.9%
100/218 • Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER