Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (CONFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00451451
Recruitment Status : Completed
First Posted : March 23, 2007
Results First Posted : June 2, 2014
Last Update Posted : January 26, 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: BG00012
Drug: Placebo
Drug: Glatiramer Acetate
Enrollment 1417
Recruitment Details Subjects were randomized at 205 investigational sites in 28 countries.
Pre-assignment Details From screening, 1430 eligible subjects were equally randomized. Of these, 1417 subjects received at least one dose of study treatment and comprised the intent-to-treat (ITT) and safety populations.
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description Participants received two placebo capsules orally three times daily (TID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) Participants received two 120 mg BG00012 capsules orally three times daily (TID) Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Period Title: Overall Study
Started 363 [1] 359 [2] 345 [3] 350 [4]
Completed 278 284 273 292
Not Completed 85 75 72 58
Reason Not Completed
Adverse Event             11             21             26             10
Lost to Follow-up             11             9             8             11
Consent Withdrawn             14             9             17             17
Investigator Decision             6             2             1             2
Subject Non-Compliance             8             4             3             3
Death             1             0             0             1
Other Reasons for Not Completing Study             34             30             17             14
[1]
363 participants were dosed; 363 participants were randomized
[2]
359 participants were dosed; 362 participants were randomized
[3]
345 participants were dosed; 345 participants were randomized
[4]
350 participants were dosed; 360 participants were randomized
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) Total
Hide Arm/Group Description Participants received two placebo capsules orally three times daily (TID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) Participants received two 120 mg BG00012 capsules orally three times daily (TID) Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD) Total of all reporting groups
Overall Number of Baseline Participants 363 359 345 350 1417
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
36.9  (9.24) 37.8  (9.35) 37.8  (9.39) 36.7  (9.06) 37.3  (9.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
Female
251
  69.1%
245
  68.2%
250
  72.5%
247
  70.6%
993
  70.1%
Male
112
  30.9%
114
  31.8%
95
  27.5%
103
  29.4%
424
  29.9%
Mean Expanded Disability Status Scale (EDSS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
2.59  (1.170) 2.56  (1.202) 2.52  (1.185) 2.57  (1.223) 2.56  (1.194)
[1]
Measure Description: The EDSS scores range from 0.0 (normal exam) to 10.0 (death due to MS).
Mean number of relapses within the previous 3 years  
Mean (Standard Deviation)
Unit of measure:  Number of relapses
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
2.5  (1.46) 2.4  (1.27) 2.6  (1.50) 2.4  (1.32) 2.5  (1.39)
Mean number of relapses within the past 12 months  
Mean (Standard Deviation)
Unit of measure:  Number of relapses
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
1.4  (0.80) 1.3  (0.63) 1.4  (0.72) 1.4  (0.64) 1.4  (0.70)
Time since first multiple sclerosis (MS) diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
4.8  (5.01) 4.9  (5.11) 4.6  (5.23) 4.4  (4.70) 4.7  (5.01)
Mean number of Gadolinium(Gd)-enhancing T1-weighted lesions   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of Gd enhancing lesions
Number Analyzed 363 participants 359 participants 345 participants 350 participants 1417 participants
2.7  (7.71) 2.7  (6.22) 1.9  (5.02) 2.4  (6.81) 2.4  (6.51)
[1]
Measure Description: This baseline measure could only be assessed in the magnetic resonance imaging (MRI) cohort. The MRI cohort included 681 intent-to-treat (ITT) subjects who were enrolled at sites that participated in the MRI portion of the study and who had MRI data (167 placebo, 169 BG00012 BID, 170 BG00012 TID, and 175 GA). Sites could participate only if their MRI capability was validated by the independent MRI reading center. Approximately 95% of all subjects enrolled at MRI sites participated in the MRI portion of the study.
1.Primary Outcome
Title Annualized Relapse Rate
Hide Description

A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.

The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description:
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Overall Number of Participants Analyzed 363 359 345 350
Mean (95% Confidence Interval)
Unit of Measure: Relapses Per Year
0.401
(0.329 to 0.488)
0.224
(0.179 to 0.282)
0.198
(0.156 to 0.252)
0.286
(0.232 to 0.353)
2.Secondary Outcome
Title Number of New or Newly Enlarging T2 Hyperintense Lesions
Hide Description The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description:
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Overall Number of Participants Analyzed 139 140 140 153
Mean (95% Confidence Interval)
Unit of Measure: Number of lesions
17.4
(13.5 to 22.4)
5.1
(3.9 to 6.6)
4.7
(3.6 to 6.2)
8.0
(6.3 to 10.2)
3.Secondary Outcome
Title Number of New T1 Hypointense Lesions
Hide Description The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description:
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Overall Number of Participants Analyzed 139 140 140 153
Mean (95% Confidence Interval)
Unit of Measure: Number of lesions
7.0
(5.3 to 9.2)
3.0
(2.3 to 4.0)
2.4
(1.8 to 3.2)
4.1
(3.2 to 5.3)
4.Secondary Outcome
Title Proportion of Subjects Relapsed
Hide Description A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description:
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Overall Number of Participants Analyzed 363 359 345 350
Measure Type: Number
Unit of Measure: Proportion of subjects,confirmed relapse
0.410 0.291 0.241 0.321
5.Secondary Outcome
Title Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Hide Description EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description:
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Overall Number of Participants Analyzed 363 359 345 350
Measure Type: Number
Unit of Measure: Proportion of Participants
0.169 0.128 0.130 0.156
Time Frame 2 years
Adverse Event Reporting Description The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group & included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
 
Arm/Group Title Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Total BG00012 Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Hide Arm/Group Description Participants received two placebo capsules orally three times daily (TID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) Participants received two 120 mg BG00012 capsules orally three times daily (TID) Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
All-Cause Mortality
Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Total BG00012 Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
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 BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Total BG00012 Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   79/363 (21.76%)   61/359 (16.99%)   54/344 (15.70%)   115/703 (16.36%)   60/351 (17.09%) 
Cardiac disorders           
BRADYCARDIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
MYOCARDITIS  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Ear and labyrinth disorders           
VESTIBULAR ATAXIA  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Eye disorders           
EYE PAIN  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
HOLMES-ADIE PUPIL  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
VISUAL ACUITY REDUCED  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Gastrointestinal disorders           
ABDOMINAL PAIN  1  0/363 (0.00%)  2/359 (0.56%)  0/344 (0.00%)  2/703 (0.28%)  0/351 (0.00%) 
VOMITING  1  1/363 (0.28%)  1/359 (0.28%)  1/344 (0.29%)  2/703 (0.28%)  0/351 (0.00%) 
DIVERTICULAR PERFORATION  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
DUODENITIS  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
INTESTINAL OBSTRUCTION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
NAUSEA  1  1/363 (0.28%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
UMBILICAL HERNIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
PANCREATITIS ACUTE  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
General disorders           
ASTHENIA  1  1/363 (0.28%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
HERNIA OBSTRUCTIVE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
OEDEMA PERIPHERAL  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
PYREXIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
Hepatobiliary disorders           
BILE DUCT STONE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
CHOLELITHIASIS  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
Immune system disorders           
ANAPHYLACTIC REACTION  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  2/351 (0.57%) 
HYPERSENSITIVITY  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Infections and infestations           
GASTROENTERITIS  1  0/363 (0.00%)  2/359 (0.56%)  2/344 (0.58%)  4/703 (0.57%)  0/351 (0.00%) 
CELLULITIS  1  0/363 (0.00%)  2/359 (0.56%)  1/344 (0.29%)  3/703 (0.43%)  0/351 (0.00%) 
URINARY TRACT INFECTION  1  0/363 (0.00%)  1/359 (0.28%)  1/344 (0.29%)  2/703 (0.28%)  0/351 (0.00%) 
DOUGLAS' ABSCESS  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
GASTROENTERITIS VIRAL  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
H1N1 INFLUENZA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
PELVIC INFLAMMATORY DISEASE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
PYELONEPHRITIS ACUTE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
VIRAL INFECTION  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  1/351 (0.28%) 
APPENDICITIS  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
BORRELIA INFECTION  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
ENDOCARDITIS BACTERIAL  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
INFLUENZA  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
PNEUMONIA  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  2/351 (0.57%) 
PYOTHORAX  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
SEPSIS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
TRACHEITIS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Injury, poisoning and procedural complications           
FEMUR FRACTURE  1  0/363 (0.00%)  1/359 (0.28%)  1/344 (0.29%)  2/703 (0.28%)  1/351 (0.28%) 
MUSCLE STRAIN  1  0/363 (0.00%)  0/359 (0.00%)  2/344 (0.58%)  2/703 (0.28%)  0/351 (0.00%) 
ALCOHOL POISONING  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
FACIAL BONES FRACTURE  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
FALL  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
FOOT FRACTURE  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
LIGAMENT RUPTURE  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
OVERDOSE  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
TRAUMATIC HAEMATOMA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
WRIST FRACTURE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
EYE INJURY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
HAND FRACTURE  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
LIGAMENT INJURY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
MENISCUS LESION  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
RADIUS FRACTURE  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
TENDON RUPTURE  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
THERAPEUTIC AGENT TOXICITY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
WHIPLASH INJURY  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Investigations           
BETA 2 MICROGLOBULIN URINE INCREASED  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
HEPATIC ENZYME INCREASED  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Metabolism and nutrition disorders           
DEHYDRATION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
DIABETIC KETOACIDOSIS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN  1  0/363 (0.00%)  2/359 (0.56%)  0/344 (0.00%)  2/703 (0.28%)  0/351 (0.00%) 
ARTHRALGIA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
BURSITIS  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
OSTEOARTHRITIS  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
SPINAL OSTEOARTHRITIS  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
UTERINE LEIOMYOMA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  1/351 (0.28%) 
BASAL CELL CARCINOMA  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
BREAST NEOPLASM  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
CERVIX CARCINOMA  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
ENDOMETRIAL CANCER  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
FIBROMA  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
THYROID CANCER METASTATIC  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Nervous system disorders           
MULTIPLE SCLEROSIS RELAPSE  1  51/363 (14.05%)  39/359 (10.86%)  30/344 (8.72%)  69/703 (9.82%)  36/351 (10.26%) 
BENIGN INTRACRANIAL HYPERTENSION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
DYSARTHRIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
GRAND MAL CONVULSION  1  1/363 (0.28%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
HEADACHE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
MIGRAINE  1  1/363 (0.28%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
OCCIPITAL NEURALGIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
PARTIAL SEIZURES  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  1/351 (0.28%) 
RESTLESS LEGS SYNDROME  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
APHASIA  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
CEREBROVASCULAR ACCIDENT  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
CEREBROVASCULAR DISORDER  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
CONVULSION  1  2/363 (0.55%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
EPILEPSY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
LOSS OF CONSCIOUSNESS  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
MULTIPLE SCLEROSIS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
ABORTION SPONTANEOUS  1  2/363 (0.55%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
GESTATIONAL OEDEMA  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Psychiatric disorders           
BIPOLAR I DISORDER  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
DEPRESSION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  2/351 (0.57%) 
SUICIDE ATTEMPT  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
ANXIETY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
COMPLETED SUICIDE  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
SUICIDAL IDEATION  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Renal and urinary disorders           
BLADDER DYSFUNCTION  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
BLADDER PERFORATION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
URINARY INCONTINENCE  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
BLADDER DIVERTICULUM  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
NEPHROPTOSIS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Reproductive system and breast disorders           
MENORRHAGIA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
METRORRHAGIA  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  1/351 (0.28%) 
BARTHOLIN'S CYST  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
UTERINE HAEMORRHAGE  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Respiratory, thoracic and mediastinal disorders           
ASTHMA  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
NASAL POLYPS  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Social circumstances           
SOCIAL PROBLEM  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Surgical and medical procedures           
BREAST LUMP REMOVAL  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
INTERVERTEBRAL DISC OPERATION  1  0/363 (0.00%)  0/359 (0.00%)  1/344 (0.29%)  1/703 (0.14%)  0/351 (0.00%) 
MEDICAL DIET  1  0/363 (0.00%)  1/359 (0.28%)  0/344 (0.00%)  1/703 (0.14%)  0/351 (0.00%) 
CERVICAL CONISATION  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
STERILISATION  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
TURBINECTOMY  1  1/363 (0.28%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  0/351 (0.00%) 
Vascular disorders           
DEEP VEIN THROMBOSIS  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  1/351 (0.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BG00012 240 mg Twice Daily (BID) BG00012 240 mg 3 Times Daily (TID) Total BG00012 Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   332/363 (91.46%)   336/359 (93.59%)   316/344 (91.86%)   652/703 (92.75%)   303/351 (86.32%) 
Ear and labyrinth disorders           
VERTIGO  1  22/363 (6.06%)  9/359 (2.51%)  13/344 (3.78%)  22/703 (3.13%)  15/351 (4.27%) 
Gastrointestinal disorders           
DIARRHEA  1  28/363 (7.71%)  45/359 (12.53%)  50/344 (14.53%)  95/703 (13.51%)  14/351 (3.99%) 
NAUSEA  1  29/363 (7.99%)  40/359 (11.14%)  51/344 (14.83%)  91/703 (12.94%)  15/351 (4.27%) 
ABDOMINAL PAIN UPPER  1  17/363 (4.68%)  36/359 (10.03%)  33/344 (9.59%)  69/703 (9.82%)  4/351 (1.14%) 
ABDOMINAL PAIN  1  15/363 (4.13%)  25/359 (6.96%)  26/344 (7.56%)  51/703 (7.25%)  4/351 (1.14%) 
VOMITING  1  12/363 (3.31%)  25/359 (6.96%)  23/344 (6.69%)  48/703 (6.83%)  8/351 (2.28%) 
DYSPEPSIA  1  8/363 (2.20%)  12/359 (3.34%)  16/344 (4.65%)  28/703 (3.98%)  6/351 (1.71%) 
General disorders           
FATIGUE  1  33/363 (9.09%)  37/359 (10.31%)  33/344 (9.59%)  70/703 (9.96%)  30/351 (8.55%) 
PYREXIA  1  19/363 (5.23%)  11/359 (3.06%)  24/344 (6.98%)  35/703 (4.98%)  17/351 (4.84%) 
INJECTION SITE ERYTHEMA  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  31/351 (8.83%) 
INJECTION SITE PAIN  1  0/363 (0.00%)  0/359 (0.00%)  0/344 (0.00%)  0/703 (0.00%)  29/351 (8.26%) 
Infections and infestations           
NASOPHARYNGITIS  1  58/363 (15.98%)  62/359 (17.27%)  63/344 (18.31%)  125/703 (17.78%)  51/351 (14.53%) 
URINARY TRACT INFECTION  1  42/363 (11.57%)  51/359 (14.21%)  40/344 (11.63%)  91/703 (12.94%)  46/351 (13.11%) 
UPPER RESPIRATORY TRACT INFECTION  1  34/363 (9.37%)  36/359 (10.03%)  47/344 (13.66%)  83/703 (11.81%)  27/351 (7.69%) 
INFLUENZA  1  22/363 (6.06%)  20/359 (5.57%)  25/344 (7.27%)  45/703 (6.40%)  15/351 (4.27%) 
BRONCHITIS  1  14/363 (3.86%)  14/359 (3.90%)  22/344 (6.40%)  36/703 (5.12%)  16/351 (4.56%) 
SINUSITIS  1  11/363 (3.03%)  18/359 (5.01%)  18/344 (5.23%)  36/703 (5.12%)  11/351 (3.13%) 
Investigations           
ALANINE AMINOTRANSFERASE INCREASED  1  25/363 (6.89%)  16/359 (4.46%)  22/344 (6.40%)  38/703 (5.41%)  20/351 (5.70%) 
ALBUMIN URINE PRESENT  1  15/363 (4.13%)  22/359 (6.13%)  14/344 (4.07%)  36/703 (5.12%)  18/351 (5.13%) 
PROTEIN URINE PRESENT  1  10/363 (2.75%)  18/359 (5.01%)  7/344 (2.03%)  25/703 (3.56%)  15/351 (4.27%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN  1  33/363 (9.09%)  34/359 (9.47%)  36/344 (10.47%)  70/703 (9.96%)  32/351 (9.12%) 
ARTHRALGIA  1  26/363 (7.16%)  20/359 (5.57%)  27/344 (7.85%)  47/703 (6.69%)  17/351 (4.84%) 
PAIN IN EXTREMITY  1  29/363 (7.99%)  21/359 (5.85%)  26/344 (7.56%)  47/703 (6.69%)  21/351 (5.98%) 
MUSCLE SPASMS  1  14/363 (3.86%)  13/359 (3.62%)  21/344 (6.10%)  34/703 (4.84%)  8/351 (2.28%) 
Nervous system disorders           
MULTIPLE SCLEROSIS RELAPSE  1  147/363 (40.50%)  104/359 (28.97%)  81/344 (23.55%)  185/703 (26.32%)  115/351 (32.76%) 
HEADACHE  1  49/363 (13.50%)  52/359 (14.48%)  46/344 (13.37%)  98/703 (13.94%)  46/351 (13.11%) 
PARAESTHESIA  1  31/363 (8.54%)  21/359 (5.85%)  21/344 (6.10%)  42/703 (5.97%)  15/351 (4.27%) 
HYPOAESTHESIA  1  21/363 (5.79%)  11/359 (3.06%)  19/344 (5.52%)  30/703 (4.27%)  16/351 (4.56%) 
Psychiatric disorders           
DEPRESSION  1  35/363 (9.64%)  24/359 (6.69%)  15/344 (4.36%)  39/703 (5.55%)  28/351 (7.98%) 
INSOMNIA  1  18/363 (4.96%)  15/359 (4.18%)  10/344 (2.91%)  25/703 (3.56%)  13/351 (3.70%) 
Renal and urinary disorders           
PROTEINURIA  1  25/363 (6.89%)  29/359 (8.08%)  35/344 (10.17%)  64/703 (9.10%)  30/351 (8.55%) 
MICROALBUMINURIA  1  13/363 (3.58%)  14/359 (3.90%)  19/344 (5.52%)  33/703 (4.69%)  15/351 (4.27%) 
Respiratory, thoracic and mediastinal disorders           
COUGH  1  17/363 (4.68%)  16/359 (4.46%)  18/344 (5.23%)  34/703 (4.84%)  9/351 (2.56%) 
OROPHARYNGEAL PAIN  1  14/363 (3.86%)  12/359 (3.34%)  21/344 (6.10%)  33/703 (4.69%)  15/351 (4.27%) 
Skin and subcutaneous tissue disorders           
RASH  1  13/363 (3.58%)  24/359 (6.69%)  28/344 (8.14%)  52/703 (7.40%)  8/351 (2.28%) 
PRURITIS  1  11/363 (3.03%)  20/359 (5.57%)  24/344 (6.98%)  44/703 (6.26%)  7/351 (1.99%) 
ERYTHEMA  1  5/363 (1.38%)  16/359 (4.46%)  21/344 (6.10%)  37/703 (5.26%)  6/351 (1.71%) 
Vascular disorders           
FLUSHING  1  13/363 (3.58%)  110/359 (30.64%)  83/344 (24.13%)  193/703 (27.45%)  6/351 (1.71%) 
HOT FLUSH  1  8/363 (2.20%)  18/359 (5.01%)  19/344 (5.52%)  37/703 (5.26%)  4/351 (1.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.
The provisions of our agreement are 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 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
Layout table for Results Point of Contact information
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
EMail: clinicaltrials@biogenidec.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00451451     History of Changes
Other Study ID Numbers: 109MS302
First Submitted: March 21, 2007
First Posted: March 23, 2007
Results First Submitted: May 5, 2014
Results First Posted: June 2, 2014
Last Update Posted: January 26, 2015