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Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)

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ClinicalTrials.gov Identifier: NCT01864148
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: BIIB033
Other: Placebo
Drug: Avonex
Enrollment 419
Recruitment Details  
Pre-assignment Details A total of 419 participants were randomized; 1 participant was not dosed.
Arm/Group Title Placebo BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg
Hide Arm/Group Description

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Period Title: Overall Study
Started 93 45 95 94 92
Randomized and Dosed 93 45 95 93 92
Completed 73 40 84 68 69
Not Completed 20 5 11 26 23
Reason Not Completed
Not Specified             2             1             1             3             1
Death             0             0             0             1             0
Investigator Decision             5             0             0             4             6
Withdrawal by Subject             9             2             6             8             8
Lost to Follow-up             0             0             0             2             1
Adverse Event             4             2             4             7             7
Not Dosed             0             0             0             1             0
Arm/Group Title Placebo BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg Total
Hide Arm/Group Description

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Total of all reporting groups
Overall Number of Baseline Participants 93 45 95 93 92 418
Hide Baseline Analysis Population Description
Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 45 participants 95 participants 93 participants 92 participants 418 participants
39.5  (9.29) 36.5  (9.47) 40.5  (9.78) 40.9  (9.70) 39.8  (9.10) 39.8  (9.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 45 participants 95 participants 93 participants 92 participants 418 participants
Female
67
  72.0%
24
  53.3%
59
  62.1%
61
  65.6%
66
  71.7%
277
  66.3%
Male
26
  28.0%
21
  46.7%
36
  37.9%
32
  34.4%
26
  28.3%
141
  33.7%
1.Primary Outcome
Title Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Hide Description 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.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg
Hide Arm/Group Description:

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Overall Number of Participants Analyzed 91 45 94 91 91
Measure Type: Number
Unit of Measure: proportion of participants
0.516 0.511 0.656 0.688 0.412
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 3 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9584
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.46 to 2.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0636
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
0.97 to 3.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 30 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0220
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.06
Confidence Interval (2-Sided) 95%
1.11 to 3.84
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 100 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1771
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.36 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 3 mg/kg, BIIB033, 10 mg/kg, BIIB033, 30 mg/kg, BIIB033, 100 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8931
Comments [Not Specified]
Method Trend test
Comments Trend test p-value is based on a linear contrast in logistic regression.
2.Secondary Outcome
Title Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
Hide Description 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.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg
Hide Arm/Group Description:

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Overall Number of Participants Analyzed 91 45 94 91 91
Measure Type: Number
Unit of Measure: proportion of participants
0.403 0.304 0.509 0.489 0.369
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 3 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3058
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.28 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1873
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.81 to 2.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 30 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2766
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
0.76 to 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 100 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6578
Comments [Not Specified]
Method Regression, Logistic
Comments Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.45 to 1.65
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033, 3 mg/kg, BIIB033, 10 mg/kg, BIIB033, 30 mg/kg, BIIB033, 100 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5255
Comments [Not Specified]
Method Trend test
Comments Trend test p-value is based on a linear contrast in logistic regression.
3.Secondary Outcome
Title Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Hide Description 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.
Time Frame Up to 84 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg BIIB033 Total
Hide Arm/Group Description:

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
Overall Number of Participants Analyzed 93 45 95 93 92 325
Measure Type: Number
Unit of Measure: participants
Any event 79 39 84 79 73 275
Moderate or severe event 59 26 59 59 58 202
Severe event 7 2 6 6 7 21
BIIB033/placebo-related event 8 8 15 12 16 51
Avonex-related event 51 28 58 54 50 190
Serious event 13 4 11 20 16 51
BIIB033/placebo-related serious event 1 0 0 1 5 6
Avonex-related serious event 1 0 0 2 1 3
Event leading to discontinuation of treatment 4 2 3 7 8 20
Event leading to withdrawal from study 4 2 4 8 7 21
4.Secondary Outcome
Title Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Hide Description [Not Specified]
Time Frame Up to 84 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data point on record.
Arm/Group Title BIIB033, 3 mg/kg BIIB033, 10 mg/kg BIIB033, 30 mg/kg BIIB033, 100 mg/kg
Hide Arm/Group Description:

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

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 once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Overall Number of Participants Analyzed 45 95 92 92
Mean (Standard Deviation)
Unit of Measure: µg/mL
Baseline, predose; n=44, 95, 92, 92 0.00  (0.00) 0.01  (0.13) 7.79  (74.75) 0.42  (4.07)
Baseline, postdose; n=44, 95, 91, 92 66.70  (16.00) 244.76  (77.90) 688.47  (245.73) 2298.20  (712.91)
Week 4, predose; n=45, 93, 91, 88 10.82  (4.11) 46.28  (33.15) 138.54  (92.82) 457.96  (308.09)
Week 4, postdose; n=45, 94, 89, 85 123.96  (315.66) 279.67  (100.01) 784.08  (204.31) 2763.26  (823.42)
Week 8, predose; n=45, 95, 89, 85 23.55  (54.96) 65.48  (52.53) 195.29  (118.24) 603.11  (425.58)
Week 8, postdose; n=44, 94, 88, 79 86.29  (52.74) 294.44  (78.61) 861.60  (274.56) 2751.25  (697.42)
Week 16, predose; n=43, 94, 86, 79 19.96  (9.74) 71.80  (25.13) 231.94  (125.42) 695.11  (438.57)
Week 16, postdose; n=41, 93, 85, 78 85.95  (29.04) 309.38  (83.38) 881.45  (211.32) 2921.09  (1118.88)
Week 24, predose; n=42, 93, 85, 74 36.41  (85.48) 77.88  (33.68) 230.46  (77.40) 699.63  (400.49)
Week 24, postdose; n=42, 92, 82, 76 144.12  (373.36) 318.01  (84.74) 940.29  (231.35) 2870.29  (874.28)
Week 36, predose; n=41, 88, 79, 74 25.33  (18.28) 85.05  (44.67) 238.48  (73.75) 725.22  (344.01)
Week 36, postdose; n=42, 88, 77, 73 94.62  (21.89) 339.17  (88.96) 197.86  (197.96) 3048.66  (989.34)
Week 48, predose; n=39, 85, 74, 70 20.78  (6.26) 80.28  (31.62) 272.88  (167.79) 806.70  (541.78)
Week 48, postdose; n=42, 85, 75, 72 90.07  (23.37) 334.12  (78.43) 955.25  (193.34) 3167.07  (1144.25)
Week 60, predose; n=41, 84, 70, 68 21.29  (12.34) 81.77  (30.24) 243.18  (78.57) 694.12  (200.41)
Week 60, postdose; n=42, 84, 71, 71 93.11  (35.98) 335.10  (93.29) 939.17  (255.64) 3330.70  (1076.88)
Week 72, predose; n=41, 85, 72, 68 19.53  (9.34) 78.94  (29.95) 215.09  (62.98) 819.39  (577.60)
Week 72, postdose; n=38, 84, 69, 68 82.96  (31.84) 313.13  (87.22) 868.39  (231.14) 3145.82  (1233.66)
Week 84; n=40, 81, 69, 69 2.44  (1.25) 12.77  (6.80) 46.16  (31.52) 127.69  (65.46)
Time Frame From first dosing of study treatment through end of study (Week 84)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BIIB033 3 mg/kg BIIB033 10 mg/kg BIIB033 30 mg/kg BIIB033 100 mg/kg
Hide Arm/Group Description

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

BIIB033 3 mg/kg once every 4 weeks IV infusion BIIB033 10 mg/kg once every 4 weeks IV infusion BIIB033 30 mg/kg once every 4 weeks IV infusion BIIB033 100 mg/kg once every 4 weeks IV infusion
All-Cause Mortality
Placebo BIIB033 3 mg/kg BIIB033 10 mg/kg BIIB033 30 mg/kg BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo BIIB033 3 mg/kg BIIB033 10 mg/kg BIIB033 30 mg/kg BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/93 (13.98%)   4/45 (8.89%)   11/95 (11.58%)   20/93 (21.51%)   16/92 (17.39%) 
Blood and lymphatic system disorders           
Hypochromic anaemia  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Cardiac disorders           
Acute myocardial infarction  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Myocardial infarction  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Myocardial ischaemia  1  0/93 (0.00%)  1/45 (2.22%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Gastrointestinal disorders           
Ileus  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Pancreatitis  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Small intestinal obstruction  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Hepatobiliary disorders           
Bile duct stone  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Cholecystitis acute  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Drug-induced liver injury  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Immune system disorders           
Hypersensitivity  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  4/92 (4.35%) 
Infections and infestations           
Cystitis  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Urinary tract infection  1  2/93 (2.15%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Injury, poisoning and procedural complications           
Fall  1  0/93 (0.00%)  1/45 (2.22%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Femur fracture  1  0/93 (0.00%)  1/45 (2.22%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Intentional overdose  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Road traffic accident  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Investigations           
Hepatic enzyme increased  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Metabolism and nutrition disorders           
Diabetes mellitus inadequate control  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Musculoskeletal and connective tissue disorders           
Osteoarthritis  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Malignant melanoma  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Thyroid adenoma  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Uterine leiomyoma  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Nervous system disorders           
Multiple sclerosis  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Multiple sclerosis relapse  1  7/93 (7.53%)  2/45 (4.44%)  6/95 (6.32%)  10/93 (10.75%)  6/92 (6.52%) 
Radicular syndrome  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Secondary progressive multiple sclerosis  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Seizure  1  1/93 (1.08%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Trigeminal neuralgia  1  0/93 (0.00%)  1/45 (2.22%)  0/95 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Psychiatric disorders           
Acute psychosis  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Anxiety  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Bipolar disorder  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Bipolar I disorder  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Suicidal ideation  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Menorrhagia  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Metrorrhagia  1  0/93 (0.00%)  0/45 (0.00%)  1/95 (1.05%)  0/93 (0.00%)  0/92 (0.00%) 
Uterine polyp  1  0/93 (0.00%)  0/45 (0.00%)  0/95 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BIIB033 3 mg/kg BIIB033 10 mg/kg BIIB033 30 mg/kg BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   74/93 (79.57%)   38/45 (84.44%)   79/95 (83.16%)   70/93 (75.27%)   67/92 (72.83%) 
Gastrointestinal disorders           
Diarrhoea  1  3/93 (3.23%)  5/45 (11.11%)  3/95 (3.16%)  3/93 (3.23%)  3/92 (3.26%) 
General disorders           
Asthenia  1  8/93 (8.60%)  1/45 (2.22%)  5/95 (5.26%)  6/93 (6.45%)  3/92 (3.26%) 
Chills  1  5/93 (5.38%)  4/45 (8.89%)  4/95 (4.21%)  8/93 (8.60%)  4/92 (4.35%) 
Fatigue  1  8/93 (8.60%)  6/45 (13.33%)  5/95 (5.26%)  7/93 (7.53%)  7/92 (7.61%) 
Influenza like illness  1  37/93 (39.78%)  17/45 (37.78%)  51/95 (53.68%)  34/93 (36.56%)  38/92 (41.30%) 
Pyrexia  1  7/93 (7.53%)  9/45 (20.00%)  8/95 (8.42%)  12/93 (12.90%)  11/92 (11.96%) 
Infections and infestations           
Influenza  1  4/93 (4.30%)  3/45 (6.67%)  6/95 (6.32%)  4/93 (4.30%)  6/92 (6.52%) 
Nasopharyngitis  1  16/93 (17.20%)  3/45 (6.67%)  12/95 (12.63%)  8/93 (8.60%)  10/92 (10.87%) 
Pharyngitis  1  2/93 (2.15%)  5/45 (11.11%)  4/95 (4.21%)  3/93 (3.23%)  3/92 (3.26%) 
Sinusitis  1  5/93 (5.38%)  2/45 (4.44%)  2/95 (2.11%)  0/93 (0.00%)  2/92 (2.17%) 
Upper respiratory tract infection  1  13/93 (13.98%)  4/45 (8.89%)  21/95 (22.11%)  11/93 (11.83%)  9/92 (9.78%) 
Urinary tract infection  1  12/93 (12.90%)  7/45 (15.56%)  14/95 (14.74%)  9/93 (9.68%)  13/92 (14.13%) 
Injury, poisoning and procedural complications           
Fall  1  10/93 (10.75%)  0/45 (0.00%)  4/95 (4.21%)  8/93 (8.60%)  5/92 (5.43%) 
Investigations           
Alanine aminotransferase increased  1  3/93 (3.23%)  2/45 (4.44%)  5/95 (5.26%)  6/93 (6.45%)  7/92 (7.61%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  3/93 (3.23%)  2/45 (4.44%)  4/95 (4.21%)  7/93 (7.53%)  3/92 (3.26%) 
Back pain  1  9/93 (9.68%)  3/45 (6.67%)  9/95 (9.47%)  6/93 (6.45%)  6/92 (6.52%) 
Muscle spasms  1  3/93 (3.23%)  3/45 (6.67%)  2/95 (2.11%)  2/93 (2.15%)  1/92 (1.09%) 
Musculoskeletal pain  1  1/93 (1.08%)  3/45 (6.67%)  1/95 (1.05%)  2/93 (2.15%)  2/92 (2.17%) 
Myalgia  1  5/93 (5.38%)  1/45 (2.22%)  5/95 (5.26%)  4/93 (4.30%)  3/92 (3.26%) 
Pain in extremity  1  4/93 (4.30%)  5/45 (11.11%)  5/95 (5.26%)  7/93 (7.53%)  1/92 (1.09%) 
Nervous system disorders           
Headache  1  23/93 (24.73%)  8/45 (17.78%)  19/95 (20.00%)  13/93 (13.98%)  11/92 (11.96%) 
Multiple sclerosis relapse  1  30/93 (32.26%)  17/45 (37.78%)  35/95 (36.84%)  36/93 (38.71%)  28/92 (30.43%) 
Psychiatric disorders           
Anxiety  1  4/93 (4.30%)  0/45 (0.00%)  5/95 (5.26%)  2/93 (2.15%)  3/92 (3.26%) 
Depressed mood  1  2/93 (2.15%)  3/45 (6.67%)  1/95 (1.05%)  2/93 (2.15%)  1/92 (1.09%) 
Depression  1  6/93 (6.45%)  2/45 (4.44%)  6/95 (6.32%)  7/93 (7.53%)  2/92 (2.17%) 
Insomnia  1  1/93 (1.08%)  2/45 (4.44%)  4/95 (4.21%)  6/93 (6.45%)  5/92 (5.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Biogen Study Medical Director
Organization: Biogen
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01864148     History of Changes
Other Study ID Numbers: 215MS201
2011-006262-40 ( EudraCT Number )
First Submitted: May 24, 2013
First Posted: May 29, 2013
Results First Submitted: March 23, 2017
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017