Trial Outcomes & Findings for Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (NCT NCT01864148)
NCT ID: NCT01864148
Last Updated: 2017-05-03
Results Overview
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
419 participants
Primary outcome timeframe
72 weeks
Results posted on
2017-05-03
Participant Flow
A total of 419 participants were randomized; 1 participant was not dosed.
Participant milestones
| Measure |
Placebo
Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84.
|
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
|---|---|---|---|---|---|
|
Overall Study
COMPLETED
|
73
|
40
|
84
|
68
|
69
|
|
Overall Study
NOT COMPLETED
|
20
|
5
|
11
|
26
|
23
|
|
Overall Study
STARTED
|
93
|
45
|
95
|
94
|
92
|
|
Overall Study
Randomized and Dosed
|
93
|
45
|
95
|
93
|
92
|
Reasons for withdrawal
| Measure |
Placebo
Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84.
|
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
2
|
1
|
1
|
3
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Investigator Decision
|
5
|
0
|
0
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
6
|
8
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
4
|
7
|
7
|
|
Overall Study
Not Dosed
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Baseline characteristics by cohort
| Measure |
Placebo
n=93 Participants
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 3 mg/kg
n=45 Participants
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
n=95 Participants
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
n=93 Participants
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
n=92 Participants
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
Total
n=418 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 9.70 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 9.10 • n=21 Participants
|
39.8 years
STANDARD_DEVIATION 9.51 • n=8 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
277 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
141 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 72 weeksPopulation: Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Outcome measures
| Measure |
Placebo
n=91 Participants
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 3 mg/kg
n=45 Participants
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
n=94 Participants
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
n=91 Participants
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
n=91 Participants
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 Total
BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
|
0.516 proportion of participants
|
0.511 proportion of participants
|
0.656 proportion of participants
|
0.688 proportion of participants
|
0.412 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 72 weeksPopulation: Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).
Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.
Outcome measures
| Measure |
Placebo
n=91 Participants
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 3 mg/kg
n=45 Participants
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
n=94 Participants
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
n=91 Participants
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
n=91 Participants
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 Total
BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
|
0.403 proportion of participants
|
0.304 proportion of participants
|
0.509 proportion of participants
|
0.489 proportion of participants
|
0.369 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 84 weeksPopulation: Safety Population: all participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.
Outcome measures
| Measure |
Placebo
n=93 Participants
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 3 mg/kg
n=45 Participants
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
n=95 Participants
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
n=93 Participants
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
n=92 Participants
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 Total
n=325 Participants
BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
BIIB033/placebo-related event
|
8 participants
|
8 participants
|
15 participants
|
12 participants
|
16 participants
|
51 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Avonex-related event
|
51 participants
|
28 participants
|
58 participants
|
54 participants
|
50 participants
|
190 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Serious event
|
13 participants
|
4 participants
|
11 participants
|
20 participants
|
16 participants
|
51 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
BIIB033/placebo-related serious event
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
5 participants
|
6 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Avonex-related serious event
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Event leading to discontinuation of treatment
|
4 participants
|
2 participants
|
3 participants
|
7 participants
|
8 participants
|
20 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Event leading to withdrawal from study
|
4 participants
|
2 participants
|
4 participants
|
8 participants
|
7 participants
|
21 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Any event
|
79 participants
|
39 participants
|
84 participants
|
79 participants
|
73 participants
|
275 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Moderate or severe event
|
59 participants
|
26 participants
|
59 participants
|
59 participants
|
58 participants
|
202 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Severe event
|
7 participants
|
2 participants
|
6 participants
|
6 participants
|
7 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Up to 84 weeksPopulation: PK Population: participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data point on record.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 3 mg/kg
n=95 Participants
BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 10 mg/kg
n=92 Participants
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 30 mg/kg
n=92 Participants
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 Total
BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Baseline, predose; n=44, 95, 92, 92
|
0.00 µg/mL
Standard Deviation 0.00
|
0.01 µg/mL
Standard Deviation 0.13
|
7.79 µg/mL
Standard Deviation 74.75
|
0.42 µg/mL
Standard Deviation 4.07
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Baseline, postdose; n=44, 95, 91, 92
|
66.70 µg/mL
Standard Deviation 16.00
|
244.76 µg/mL
Standard Deviation 77.90
|
688.47 µg/mL
Standard Deviation 245.73
|
2298.20 µg/mL
Standard Deviation 712.91
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 4, predose; n=45, 93, 91, 88
|
10.82 µg/mL
Standard Deviation 4.11
|
46.28 µg/mL
Standard Deviation 33.15
|
138.54 µg/mL
Standard Deviation 92.82
|
457.96 µg/mL
Standard Deviation 308.09
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 4, postdose; n=45, 94, 89, 85
|
123.96 µg/mL
Standard Deviation 315.66
|
279.67 µg/mL
Standard Deviation 100.01
|
784.08 µg/mL
Standard Deviation 204.31
|
2763.26 µg/mL
Standard Deviation 823.42
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 8, predose; n=45, 95, 89, 85
|
23.55 µg/mL
Standard Deviation 54.96
|
65.48 µg/mL
Standard Deviation 52.53
|
195.29 µg/mL
Standard Deviation 118.24
|
603.11 µg/mL
Standard Deviation 425.58
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 8, postdose; n=44, 94, 88, 79
|
86.29 µg/mL
Standard Deviation 52.74
|
294.44 µg/mL
Standard Deviation 78.61
|
861.60 µg/mL
Standard Deviation 274.56
|
2751.25 µg/mL
Standard Deviation 697.42
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 16, predose; n=43, 94, 86, 79
|
19.96 µg/mL
Standard Deviation 9.74
|
71.80 µg/mL
Standard Deviation 25.13
|
231.94 µg/mL
Standard Deviation 125.42
|
695.11 µg/mL
Standard Deviation 438.57
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 16, postdose; n=41, 93, 85, 78
|
85.95 µg/mL
Standard Deviation 29.04
|
309.38 µg/mL
Standard Deviation 83.38
|
881.45 µg/mL
Standard Deviation 211.32
|
2921.09 µg/mL
Standard Deviation 1118.88
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 24, predose; n=42, 93, 85, 74
|
36.41 µg/mL
Standard Deviation 85.48
|
77.88 µg/mL
Standard Deviation 33.68
|
230.46 µg/mL
Standard Deviation 77.40
|
699.63 µg/mL
Standard Deviation 400.49
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 24, postdose; n=42, 92, 82, 76
|
144.12 µg/mL
Standard Deviation 373.36
|
318.01 µg/mL
Standard Deviation 84.74
|
940.29 µg/mL
Standard Deviation 231.35
|
2870.29 µg/mL
Standard Deviation 874.28
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 36, predose; n=41, 88, 79, 74
|
25.33 µg/mL
Standard Deviation 18.28
|
85.05 µg/mL
Standard Deviation 44.67
|
238.48 µg/mL
Standard Deviation 73.75
|
725.22 µg/mL
Standard Deviation 344.01
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 36, postdose; n=42, 88, 77, 73
|
94.62 µg/mL
Standard Deviation 21.89
|
339.17 µg/mL
Standard Deviation 88.96
|
197.86 µg/mL
Standard Deviation 197.96
|
3048.66 µg/mL
Standard Deviation 989.34
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 48, predose; n=39, 85, 74, 70
|
20.78 µg/mL
Standard Deviation 6.26
|
80.28 µg/mL
Standard Deviation 31.62
|
272.88 µg/mL
Standard Deviation 167.79
|
806.70 µg/mL
Standard Deviation 541.78
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 48, postdose; n=42, 85, 75, 72
|
90.07 µg/mL
Standard Deviation 23.37
|
334.12 µg/mL
Standard Deviation 78.43
|
955.25 µg/mL
Standard Deviation 193.34
|
3167.07 µg/mL
Standard Deviation 1144.25
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 60, predose; n=41, 84, 70, 68
|
21.29 µg/mL
Standard Deviation 12.34
|
81.77 µg/mL
Standard Deviation 30.24
|
243.18 µg/mL
Standard Deviation 78.57
|
694.12 µg/mL
Standard Deviation 200.41
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 60, postdose; n=42, 84, 71, 71
|
93.11 µg/mL
Standard Deviation 35.98
|
335.10 µg/mL
Standard Deviation 93.29
|
939.17 µg/mL
Standard Deviation 255.64
|
3330.70 µg/mL
Standard Deviation 1076.88
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 72, predose; n=41, 85, 72, 68
|
19.53 µg/mL
Standard Deviation 9.34
|
78.94 µg/mL
Standard Deviation 29.95
|
215.09 µg/mL
Standard Deviation 62.98
|
819.39 µg/mL
Standard Deviation 577.60
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 72, postdose; n=38, 84, 69, 68
|
82.96 µg/mL
Standard Deviation 31.84
|
313.13 µg/mL
Standard Deviation 87.22
|
868.39 µg/mL
Standard Deviation 231.14
|
3145.82 µg/mL
Standard Deviation 1233.66
|
—
|
—
|
|
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Week 84; n=40, 81, 69, 69
|
2.44 µg/mL
Standard Deviation 1.25
|
12.77 µg/mL
Standard Deviation 6.80
|
46.16 µg/mL
Standard Deviation 31.52
|
127.69 µg/mL
Standard Deviation 65.46
|
—
|
—
|
Adverse Events
Placebo
Serious events: 13 serious events
Other events: 74 other events
Deaths: 0 deaths
BIIB033 3 mg/kg
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
BIIB033 10 mg/kg
Serious events: 11 serious events
Other events: 79 other events
Deaths: 0 deaths
BIIB033 30 mg/kg
Serious events: 20 serious events
Other events: 70 other events
Deaths: 0 deaths
BIIB033 100 mg/kg
Serious events: 16 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=93 participants at risk
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 3 mg/kg
n=45 participants at risk
BIIB033 3 mg/kg once every 4 weeks IV infusion
|
BIIB033 10 mg/kg
n=95 participants at risk
BIIB033 10 mg/kg once every 4 weeks IV infusion
|
BIIB033 30 mg/kg
n=93 participants at risk
BIIB033 30 mg/kg once every 4 weeks IV infusion
|
BIIB033 100 mg/kg
n=92 participants at risk
BIIB033 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
4.3%
4/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Cystitis
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Multiple sclerosis relapse
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
6.3%
6/95 • From first dosing of study treatment through end of study (Week 84)
|
10.8%
10/93 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Radicular syndrome
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Secondary progressive multiple sclerosis
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Seizure
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
Other adverse events
| Measure |
Placebo
n=93 participants at risk
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
|
BIIB033 3 mg/kg
n=45 participants at risk
BIIB033 3 mg/kg once every 4 weeks IV infusion
|
BIIB033 10 mg/kg
n=95 participants at risk
BIIB033 10 mg/kg once every 4 weeks IV infusion
|
BIIB033 30 mg/kg
n=93 participants at risk
BIIB033 30 mg/kg once every 4 weeks IV infusion
|
BIIB033 100 mg/kg
n=92 participants at risk
BIIB033 100 mg/kg once every 4 weeks IV infusion
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
11.1%
5/45 • From first dosing of study treatment through end of study (Week 84)
|
3.2%
3/95 • From first dosing of study treatment through end of study (Week 84)
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
General disorders
Asthenia
|
8.6%
8/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
General disorders
Chills
|
5.4%
5/93 • From first dosing of study treatment through end of study (Week 84)
|
8.9%
4/45 • From first dosing of study treatment through end of study (Week 84)
|
4.2%
4/95 • From first dosing of study treatment through end of study (Week 84)
|
8.6%
8/93 • From first dosing of study treatment through end of study (Week 84)
|
4.3%
4/92 • From first dosing of study treatment through end of study (Week 84)
|
|
General disorders
Fatigue
|
8.6%
8/93 • From first dosing of study treatment through end of study (Week 84)
|
13.3%
6/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
7.6%
7/92 • From first dosing of study treatment through end of study (Week 84)
|
|
General disorders
Influenza like illness
|
39.8%
37/93 • From first dosing of study treatment through end of study (Week 84)
|
37.8%
17/45 • From first dosing of study treatment through end of study (Week 84)
|
53.7%
51/95 • From first dosing of study treatment through end of study (Week 84)
|
36.6%
34/93 • From first dosing of study treatment through end of study (Week 84)
|
41.3%
38/92 • From first dosing of study treatment through end of study (Week 84)
|
|
General disorders
Pyrexia
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
20.0%
9/45 • From first dosing of study treatment through end of study (Week 84)
|
8.4%
8/95 • From first dosing of study treatment through end of study (Week 84)
|
12.9%
12/93 • From first dosing of study treatment through end of study (Week 84)
|
12.0%
11/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Influenza
|
4.3%
4/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
6.3%
6/95 • From first dosing of study treatment through end of study (Week 84)
|
4.3%
4/93 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
16/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
12.6%
12/95 • From first dosing of study treatment through end of study (Week 84)
|
8.6%
8/93 • From first dosing of study treatment through end of study (Week 84)
|
10.9%
10/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Pharyngitis
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
11.1%
5/45 • From first dosing of study treatment through end of study (Week 84)
|
4.2%
4/95 • From first dosing of study treatment through end of study (Week 84)
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Sinusitis
|
5.4%
5/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
2.1%
2/95 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
13/93 • From first dosing of study treatment through end of study (Week 84)
|
8.9%
4/45 • From first dosing of study treatment through end of study (Week 84)
|
22.1%
21/95 • From first dosing of study treatment through end of study (Week 84)
|
11.8%
11/93 • From first dosing of study treatment through end of study (Week 84)
|
9.8%
9/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Infections and infestations
Urinary tract infection
|
12.9%
12/93 • From first dosing of study treatment through end of study (Week 84)
|
15.6%
7/45 • From first dosing of study treatment through end of study (Week 84)
|
14.7%
14/95 • From first dosing of study treatment through end of study (Week 84)
|
9.7%
9/93 • From first dosing of study treatment through end of study (Week 84)
|
14.1%
13/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Injury, poisoning and procedural complications
Fall
|
10.8%
10/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
4.2%
4/95 • From first dosing of study treatment through end of study (Week 84)
|
8.6%
8/93 • From first dosing of study treatment through end of study (Week 84)
|
5.4%
5/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/93 • From first dosing of study treatment through end of study (Week 84)
|
7.6%
7/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
4.2%
4/95 • From first dosing of study treatment through end of study (Week 84)
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
9/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
9.5%
9/95 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/93 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
3/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
2.1%
2/95 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
5/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
1/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
4.3%
4/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
4/93 • From first dosing of study treatment through end of study (Week 84)
|
11.1%
5/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Headache
|
24.7%
23/93 • From first dosing of study treatment through end of study (Week 84)
|
17.8%
8/45 • From first dosing of study treatment through end of study (Week 84)
|
20.0%
19/95 • From first dosing of study treatment through end of study (Week 84)
|
14.0%
13/93 • From first dosing of study treatment through end of study (Week 84)
|
12.0%
11/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Nervous system disorders
Multiple sclerosis relapse
|
32.3%
30/93 • From first dosing of study treatment through end of study (Week 84)
|
37.8%
17/45 • From first dosing of study treatment through end of study (Week 84)
|
36.8%
35/95 • From first dosing of study treatment through end of study (Week 84)
|
38.7%
36/93 • From first dosing of study treatment through end of study (Week 84)
|
30.4%
28/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Anxiety
|
4.3%
4/93 • From first dosing of study treatment through end of study (Week 84)
|
0.00%
0/45 • From first dosing of study treatment through end of study (Week 84)
|
5.3%
5/95 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
3.3%
3/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Depressed mood
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
6.7%
3/45 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/95 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/93 • From first dosing of study treatment through end of study (Week 84)
|
1.1%
1/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Depression
|
6.5%
6/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
6.3%
6/95 • From first dosing of study treatment through end of study (Week 84)
|
7.5%
7/93 • From first dosing of study treatment through end of study (Week 84)
|
2.2%
2/92 • From first dosing of study treatment through end of study (Week 84)
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/93 • From first dosing of study treatment through end of study (Week 84)
|
4.4%
2/45 • From first dosing of study treatment through end of study (Week 84)
|
4.2%
4/95 • From first dosing of study treatment through end of study (Week 84)
|
6.5%
6/93 • From first dosing of study treatment through end of study (Week 84)
|
5.4%
5/92 • From first dosing of study treatment through end of study (Week 84)
|
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