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Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS) (REFINE)

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ClinicalTrials.gov Identifier: NCT01405820
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : July 29, 2015
Last Update Posted : August 21, 2015
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 Relapsing-Remitting Multiple Sclerosis
Interventions Drug: natalizumab IV
Drug: natalizumab SC
Drug: IV Placebo
Drug: SC Placebo
Enrollment 290
Recruitment Details  
Pre-assignment Details Four of the 6 arms in the Randomized Treatment Period (the ‘every 12 weeks’ arms) were closed prematurely. Participants who completed randomized treatment, met rescue criteria, or were impacted by arm closure (and met rescue criteria) were eligible to enroll in the open-label treatment period.
Arm/Group Title Natalizumab 300 mg Intravenous (IV) Every 4 Weeks Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks Natalizumab 300 mg IV Every 12 Weeks Natalizumab 300 mg SC Every 12 Weeks Natalizumab 150 mg IV Every 12 Weeks Natalizumab 150 mg SC Every 12 Weeks
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Period Title: Randomized Treatment Period
Started 54 45 52 54 47 38
Safety Population 54 45 52 53 [1] 47 38
Completed 43 35 9 3 2 1
Not Completed 11 10 43 51 45 37
Reason Not Completed
Adverse Event             3             3             3             0             2             1
Withdrawal by Subject             6             2             2             2             0             0
Not Specified             2             2             1             1             0             0
Physician Decision             0             2             1             0             0             0
Rescue             0             1             13             10             8             8
Incorrect Study Treatment             0             0             3             0             2             0
Treatment Arm Closed             0             0             20             36             33             28
Death             0             0             0             1             0             0
Withdrew Prior to Dosing             0             0             0             1             0             0
[1]
1 participant did not receive any study medication.
Period Title: Open-Label Treatment Period
Started 44 [1] 35 42 42 42 32
Completed 40 33 39 37 40 30
Not Completed 4 2 3 5 2 2
Reason Not Completed
Withdrawal by Subject             3             1             1             1             0             1
Not Specified             1             1             1             1             1             1
Physician Decision             0             0             1             2             1             0
Adverse Event             0             0             0             1             0             0
[1]
1 participant discontinued randomized period due to an adverse event but entered open-label period.
Arm/Group Title Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks Total
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks for 60 weeks. Natalizumab 300 mg SC every 4 weeks for 60 weeks. Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Total of all reporting groups
Overall Number of Baseline Participants 54 45 52 54 47 38 290
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 45 participants 52 participants 54 participants 47 participants 38 participants 290 participants
38.4  (7.84) 36.3  (8.92) 38.7  (8.43) 38.7  (7.85) 38.7  (8.61) 36.0  (9.03) 37.9  (8.41)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 45 participants 52 participants 54 participants 47 participants 38 participants 290 participants
18 to 19 years 0 1 0 0 0 0 1
20 to 29 years 7 11 7 7 5 11 48
30 to 39 years 22 15 21 24 21 14 117
40 to 49 years 20 16 17 17 16 9 95
50 to 56 years 5 2 7 6 5 4 29
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 45 participants 52 participants 54 participants 47 participants 38 participants 290 participants
Female
39
  72.2%
29
  64.4%
37
  71.2%
41
  75.9%
34
  72.3%
24
  63.2%
204
  70.3%
Male
15
  27.8%
16
  35.6%
15
  28.8%
13
  24.1%
13
  27.7%
14
  36.8%
86
  29.7%
1.Primary Outcome
Title Cumulative Number of Combined Unique Active Lesions
Hide Description Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.
Time Frame Up to Week 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.
Arm/Group Title Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks for 60 weeks.
Natalizumab 300 mg SC every 4 weeks for 60 weeks.
Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
Overall Number of Participants Analyzed 52 44 45 50 35 32
Mean (Standard Deviation)
Unit of Measure: lesions
0.23  (1.262) 0.02  (0.151) 3.84  (8.054) 3.08  (8.216) 6.09  (15.424) 6.44  (11.285)
Time Frame AEs were analyzed during the randomized and open-label (OL) periods separately. Randomized period: AEs, after 1st randomized dose on Day 0 and prior to OL infusion of natalizumab at Week 60 (±5 days); SAEs also between Screening and dosing on Day 0.
Adverse Event Reporting Description OL period: on or after OL infusion of natalizumab at Week 60 through to Week 72 (±2 weeks). If participant did not receive natalizumab infusions during the OL period (Week 60 to Week 72), all events with an onset date after Day 0 were considered as occurring during the randomized treatment period. AE data is presented for the Safety Population.
 
Arm/Group Title Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks Open-label Period: Natalizumab 300 mg IV Every 4 Weeks Open-label Period: Natalizumab 300 mg SC Every 4 Weeks Open-label Period: Natalizumab 300 mg IV Every 12 Weeks Open-label Period: Natalizumab 300 mg SC Every 12 Weeks Open-label Period: Natalizumab 150 mg IV Every 12 Weeks Open-label Period: Natalizumab 150 mg SC Every 12 Weeks
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks for 60 weeks. Natalizumab 300 mg SC every 4 weeks for 60 weeks. Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
All-Cause Mortality
Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks Open-label Period: Natalizumab 300 mg IV Every 4 Weeks Open-label Period: Natalizumab 300 mg SC Every 4 Weeks Open-label Period: Natalizumab 300 mg IV Every 12 Weeks Open-label Period: Natalizumab 300 mg SC Every 12 Weeks Open-label Period: Natalizumab 150 mg IV Every 12 Weeks Open-label Period: Natalizumab 150 mg SC Every 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks Open-label Period: Natalizumab 300 mg IV Every 4 Weeks Open-label Period: Natalizumab 300 mg SC Every 4 Weeks Open-label Period: Natalizumab 300 mg IV Every 12 Weeks Open-label Period: Natalizumab 300 mg SC Every 12 Weeks Open-label Period: Natalizumab 150 mg IV Every 12 Weeks Open-label Period: Natalizumab 150 mg SC Every 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/54 (12.96%)   4/45 (8.89%)   4/52 (7.69%)   3/53 (5.66%)   4/47 (8.51%)   1/38 (2.63%)   0/44 (0.00%)   1/35 (2.86%)   0/42 (0.00%)   1/42 (2.38%)   1/42 (2.38%)   2/32 (6.25%) 
Gastrointestinal disorders                         
Vomiting  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Abdominal Pain  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  1/35 (2.86%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Infections and infestations                         
Appendicitis  1  0/54 (0.00%)  1/45 (2.22%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Escherichia Urinary Tract Infection  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  1/47 (2.13%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Meningitis Enteroviral  2  0/54 (0.00%)  0/45 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Progressive Multifocal Leukoencephalopathy  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Urosepsis  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Bronchitis  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  1/35 (2.86%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Injury, poisoning and procedural complications                         
Fall  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Radius Fracture  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Investigations                         
Nuclear Magnetic Resonance Imaging Abnormal  2  0/54 (0.00%)  0/45 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders                         
Intervertebral Disc Protrusion  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Carcinoma In Situ  2  0/54 (0.00%)  0/45 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Lung Adenocarcinoma Metastatic  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Nervous system disorders                         
Multiple Sclerosis Relapse  2  1/54 (1.85%)  2/45 (4.44%)  1/52 (1.92%)  0/53 (0.00%)  2/47 (4.26%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  1/42 (2.38%)  2/32 (6.25%) 
Epilepsy  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  1/47 (2.13%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Cerebrovascular Insufficiency  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Coma  2  0/54 (0.00%)  1/45 (2.22%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Polyneuropathy  2  0/54 (0.00%)  0/45 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Psychiatric disorders                         
Bipolar I Disorder  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Pathological Gambling  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Renal and urinary disorders                         
Automatic Bladder  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Urinary Retention  2  1/54 (1.85%)  0/45 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Randomized Period: Natalizumab 300 mg IV Every 4 Weeks Randomized Period: Natalizumab 300 mg SC Every 4 Weeks Randomized Period: Natalizumab 300 mg IV Every 12 Weeks Randomized Period: Natalizumab 300 mg SC Every 12 Weeks Randomized Period: Natalizumab 150 mg IV Every 12 Weeks Randomized Period: Natalizumab 150 mg SC Every 12 Weeks Open-label Period: Natalizumab 300 mg IV Every 4 Weeks Open-label Period: Natalizumab 300 mg SC Every 4 Weeks Open-label Period: Natalizumab 300 mg IV Every 12 Weeks Open-label Period: Natalizumab 300 mg SC Every 12 Weeks Open-label Period: Natalizumab 150 mg IV Every 12 Weeks Open-label Period: Natalizumab 150 mg SC Every 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/54 (74.07%)   31/45 (68.89%)   31/52 (59.62%)   34/53 (64.15%)   31/47 (65.96%)   17/38 (44.74%)   2/44 (4.55%)   4/35 (11.43%)   2/42 (4.76%)   0/42 (0.00%)   4/42 (9.52%)   6/32 (18.75%) 
Gastrointestinal disorders                         
Diarrhoea  2  4/54 (7.41%)  4/45 (8.89%)  2/52 (3.85%)  1/53 (1.89%)  4/47 (8.51%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Nausea  2  3/54 (5.56%)  4/45 (8.89%)  2/52 (3.85%)  2/53 (3.77%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Vomiting  2  1/54 (1.85%)  4/45 (8.89%)  0/52 (0.00%)  2/53 (3.77%)  1/47 (2.13%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Constipation  2  2/54 (3.70%)  1/45 (2.22%)  0/52 (0.00%)  1/53 (1.89%)  3/47 (6.38%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Abdominal Pain  2  1/54 (1.85%)  4/45 (8.89%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Toothache  2  4/54 (7.41%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
General disorders                         
Fatigue  2  6/54 (11.11%)  6/45 (13.33%)  4/52 (7.69%)  1/53 (1.89%)  2/47 (4.26%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Injection Site Pain  2  0/54 (0.00%)  1/45 (2.22%)  0/52 (0.00%)  3/53 (5.66%)  0/47 (0.00%)  3/38 (7.89%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Pyrexia  2  0/54 (0.00%)  1/45 (2.22%)  0/52 (0.00%)  1/53 (1.89%)  3/47 (6.38%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Pain  2  0/54 (0.00%)  3/45 (6.67%)  0/52 (0.00%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Infections and infestations                         
Nasopharyngitis  1  13/54 (24.07%)  8/45 (17.78%)  8/52 (15.38%)  9/53 (16.98%)  8/47 (17.02%)  4/38 (10.53%)  2/44 (4.55%)  1/35 (2.86%)  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  2/32 (6.25%) 
Urinary Tract Infection  1  8/54 (14.81%)  5/45 (11.11%)  3/52 (5.77%)  4/53 (7.55%)  4/47 (8.51%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Influenza  2  4/54 (7.41%)  2/45 (4.44%)  1/52 (1.92%)  2/53 (3.77%)  8/47 (17.02%)  0/38 (0.00%)  0/44 (0.00%)  1/35 (2.86%)  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  3/32 (9.38%) 
Pharyngitis  2  3/54 (5.56%)  1/45 (2.22%)  1/52 (1.92%)  1/53 (1.89%)  4/47 (8.51%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Bronchitis  2  2/54 (3.70%)  3/45 (6.67%)  0/52 (0.00%)  4/53 (7.55%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  2/35 (5.71%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Gastroenteritis  2  1/54 (1.85%)  3/45 (6.67%)  2/52 (3.85%)  2/53 (3.77%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Sinusitis  2  2/54 (3.70%)  0/45 (0.00%)  3/52 (5.77%)  2/53 (3.77%)  2/47 (4.26%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Oral Herpes  2  4/54 (7.41%)  1/45 (2.22%)  0/52 (0.00%)  1/53 (1.89%)  1/47 (2.13%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Investigations                         
Nuclear Magnetic Resonance Imaging Abnormal  2  0/54 (0.00%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  2/38 (5.26%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders                         
Back Pain  2  3/54 (5.56%)  2/45 (4.44%)  3/52 (5.77%)  1/53 (1.89%)  2/47 (4.26%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Pain in Extremity  2  2/54 (3.70%)  3/45 (6.67%)  2/52 (3.85%)  2/53 (3.77%)  2/47 (4.26%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Arthralgia  2  3/54 (5.56%)  4/45 (8.89%)  0/52 (0.00%)  1/53 (1.89%)  3/47 (6.38%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Nervous system disorders                         
Multiple Sclerosis Relapse  2  8/54 (14.81%)  6/45 (13.33%)  13/52 (25.00%)  17/53 (32.08%)  12/47 (25.53%)  5/38 (13.16%)  0/44 (0.00%)  0/35 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  3/42 (7.14%)  2/32 (6.25%) 
Headache  2  4/54 (7.41%)  9/45 (20.00%)  7/52 (13.46%)  5/53 (9.43%)  3/47 (6.38%)  4/38 (10.53%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Paraesthesia  2  2/54 (3.70%)  1/45 (2.22%)  2/52 (3.85%)  3/53 (5.66%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Sciatica  2  1/54 (1.85%)  1/45 (2.22%)  3/52 (5.77%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Psychiatric disorders                         
Depression  2  1/54 (1.85%)  3/45 (6.67%)  2/52 (3.85%)  1/53 (1.89%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
Oropharyngeal Pain  2  2/54 (3.70%)  1/45 (2.22%)  1/52 (1.92%)  4/53 (7.55%)  0/47 (0.00%)  1/38 (2.63%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Cough  2  3/54 (5.56%)  0/45 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Vascular disorders                         
Hypotension  2  0/54 (0.00%)  1/45 (2.22%)  3/52 (5.77%)  0/53 (0.00%)  0/47 (0.00%)  0/38 (0.00%)  0/44 (0.00%)  0/35 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA 16.1
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: NCT01405820     History of Changes
Other Study ID Numbers: 101MS206
2010-024000-10 ( EudraCT Number )
First Submitted: July 14, 2011
First Posted: July 29, 2011
Results First Submitted: June 29, 2015
Results First Posted: July 29, 2015
Last Update Posted: August 21, 2015