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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00451451
First received: March 21, 2007
Last updated: January 13, 2015
Last verified: January 2015
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
Interventions: Drug: BG00012
Drug: Placebo
Drug: Glatiramer Acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were randomized at 205 investigational sites in 28 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Participants received two placebo capsules orally three times daily (TID)
BG00012 240 mg Twice Daily (BID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012 240 mg 3 Times Daily (TID) Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Participant Flow:   Overall Study
    Placebo   BG00012 240 mg Twice Daily (BID)   BG00012 240 mg 3 Times Daily (TID)   Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
STARTED   363 [1]   359 [2]   345 [3]   350 [4] 
COMPLETED   278   284   273   292 
NOT COMPLETED   85   75   72   58 
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Consent Withdrawn                14                9                17                17 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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received two placebo capsules orally three times daily (TID)
BG00012 240 mg Twice Daily (BID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012 240 mg 3 Times Daily (TID) Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Total Total of all reporting groups

Baseline Measures
   Placebo   BG00012 240 mg Twice Daily (BID)   BG00012 240 mg 3 Times Daily (TID)   Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)   Total 
Overall Participants Analyzed 
[Units: Participants]
 363   359   345   350   1417 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.9  (9.24)   37.8  (9.35)   37.8  (9.39)   36.7  (9.06)   37.3  (9.26) 
Gender 
[Units: Participants]
         
Female   251   245   250   247   993 
Male   112   114   95   103   424 
Mean Expanded Disability Status Scale (EDSS) score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.59  (1.170)   2.56  (1.202)   2.52  (1.185)   2.57  (1.223)   2.56  (1.194) 
[1] 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 
[Units: Number of relapses]
Mean (Standard Deviation)
 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 
[Units: Number of relapses]
Mean (Standard Deviation)
 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 
[Units: Years]
Mean (Standard Deviation)
 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] 
[Units: Number of Gd enhancing lesions]
Mean (Standard Deviation)
 2.7  (7.71)   2.7  (6.22)   1.9  (5.02)   2.4  (6.81)   2.4  (6.51) 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annualized Relapse Rate   [ Time Frame: 2 years ]

2.  Secondary:   Number of New or Newly Enlarging T2 Hyperintense Lesions   [ Time Frame: 2 years ]

3.  Secondary:   Number of New T1 Hypointense Lesions   [ Time Frame: 2 years ]

4.  Secondary:   Proportion of Subjects Relapsed   [ Time Frame: 2 years ]

5.  Secondary:   Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame 2 years
Additional 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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo Participants received two placebo capsules orally three times daily (TID)
BG00012 240 mg Twice Daily (BID) Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012 240 mg 3 Times Daily (TID) Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Total BG00012 Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Other 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)
Total, Other (not including serious) Adverse Events           
# participants affected / at risk   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           
# participants affected / at risk   22/363 (6.06%)   9/359 (2.51%)   13/344 (3.78%)   22/703 (3.13%)   15/351 (4.27%) 
Gastrointestinal disorders           
DIARRHEA † 1           
# participants affected / at risk   28/363 (7.71%)   45/359 (12.53%)   50/344 (14.53%)   95/703 (13.51%)   14/351 (3.99%) 
NAUSEA † 1           
# participants affected / at risk   29/363 (7.99%)   40/359 (11.14%)   51/344 (14.83%)   91/703 (12.94%)   15/351 (4.27%) 
ABDOMINAL PAIN UPPER † 1           
# participants affected / at risk   17/363 (4.68%)   36/359 (10.03%)   33/344 (9.59%)   69/703 (9.82%)   4/351 (1.14%) 
ABDOMINAL PAIN † 1           
# participants affected / at risk   15/363 (4.13%)   25/359 (6.96%)   26/344 (7.56%)   51/703 (7.25%)   4/351 (1.14%) 
VOMITING † 1           
# participants affected / at risk   12/363 (3.31%)   25/359 (6.96%)   23/344 (6.69%)   48/703 (6.83%)   8/351 (2.28%) 
DYSPEPSIA † 1           
# participants affected / at risk   8/363 (2.20%)   12/359 (3.34%)   16/344 (4.65%)   28/703 (3.98%)   6/351 (1.71%) 
General disorders           
FATIGUE † 1           
# participants affected / at risk   33/363 (9.09%)   37/359 (10.31%)   33/344 (9.59%)   70/703 (9.96%)   30/351 (8.55%) 
PYREXIA † 1           
# participants affected / at risk   19/363 (5.23%)   11/359 (3.06%)   24/344 (6.98%)   35/703 (4.98%)   17/351 (4.84%) 
INJECTION SITE ERYTHEMA † 1           
# participants affected / at risk   0/363 (0.00%)   0/359 (0.00%)   0/344 (0.00%)   0/703 (0.00%)   31/351 (8.83%) 
INJECTION SITE PAIN † 1           
# participants affected / at risk   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           
# participants affected / at risk   58/363 (15.98%)   62/359 (17.27%)   63/344 (18.31%)   125/703 (17.78%)   51/351 (14.53%) 
URINARY TRACT INFECTION † 1           
# participants affected / at risk   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           
# participants affected / at risk   34/363 (9.37%)   36/359 (10.03%)   47/344 (13.66%)   83/703 (11.81%)   27/351 (7.69%) 
INFLUENZA † 1           
# participants affected / at risk   22/363 (6.06%)   20/359 (5.57%)   25/344 (7.27%)   45/703 (6.40%)   15/351 (4.27%) 
BRONCHITIS † 1           
# participants affected / at risk   14/363 (3.86%)   14/359 (3.90%)   22/344 (6.40%)   36/703 (5.12%)   16/351 (4.56%) 
SINUSITIS † 1           
# participants affected / at risk   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           
# participants affected / at risk   25/363 (6.89%)   16/359 (4.46%)   22/344 (6.40%)   38/703 (5.41%)   20/351 (5.70%) 
ALBUMIN URINE PRESENT † 1           
# participants affected / at risk   15/363 (4.13%)   22/359 (6.13%)   14/344 (4.07%)   36/703 (5.12%)   18/351 (5.13%) 
PROTEIN URINE PRESENT † 1           
# participants affected / at risk   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           
# participants affected / at risk   33/363 (9.09%)   34/359 (9.47%)   36/344 (10.47%)   70/703 (9.96%)   32/351 (9.12%) 
ARTHRALGIA † 1           
# participants affected / at risk   26/363 (7.16%)   20/359 (5.57%)   27/344 (7.85%)   47/703 (6.69%)   17/351 (4.84%) 
PAIN IN EXTREMITY † 1           
# participants affected / at risk   29/363 (7.99%)   21/359 (5.85%)   26/344 (7.56%)   47/703 (6.69%)   21/351 (5.98%) 
MUSCLE SPASMS † 1           
# participants affected / at risk   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           
# participants affected / at risk   147/363 (40.50%)   104/359 (28.97%)   81/344 (23.55%)   185/703 (26.32%)   115/351 (32.76%) 
HEADACHE † 1           
# participants affected / at risk   49/363 (13.50%)   52/359 (14.48%)   46/344 (13.37%)   98/703 (13.94%)   46/351 (13.11%) 
PARAESTHESIA † 1           
# participants affected / at risk   31/363 (8.54%)   21/359 (5.85%)   21/344 (6.10%)   42/703 (5.97%)   15/351 (4.27%) 
HYPOAESTHESIA † 1           
# participants affected / at risk   21/363 (5.79%)   11/359 (3.06%)   19/344 (5.52%)   30/703 (4.27%)   16/351 (4.56%) 
Psychiatric disorders           
DEPRESSION † 1           
# participants affected / at risk   35/363 (9.64%)   24/359 (6.69%)   15/344 (4.36%)   39/703 (5.55%)   28/351 (7.98%) 
INSOMNIA † 1           
# participants affected / at risk   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           
# participants affected / at risk   25/363 (6.89%)   29/359 (8.08%)   35/344 (10.17%)   64/703 (9.10%)   30/351 (8.55%) 
MICROALBUMINURIA † 1           
# participants affected / at risk   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           
# participants affected / at risk   17/363 (4.68%)   16/359 (4.46%)   18/344 (5.23%)   34/703 (4.84%)   9/351 (2.56%) 
OROPHARYNGEAL PAIN † 1           
# participants affected / at risk   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           
# participants affected / at risk   13/363 (3.58%)   24/359 (6.69%)   28/344 (8.14%)   52/703 (7.40%)   8/351 (2.28%) 
PRURITIS † 1           
# participants affected / at risk   11/363 (3.03%)   20/359 (5.57%)   24/344 (6.98%)   44/703 (6.26%)   7/351 (1.99%) 
ERYTHEMA † 1           
# participants affected / at risk   5/363 (1.38%)   16/359 (4.46%)   21/344 (6.10%)   37/703 (5.26%)   6/351 (1.71%) 
Vascular disorders           
FLUSHING † 1           
# participants affected / at risk   13/363 (3.58%)   110/359 (30.64%)   83/344 (24.13%)   193/703 (27.45%)   6/351 (1.71%) 
HOT FLUSH † 1           
# participants affected / at risk   8/363 (2.20%)   18/359 (5.01%)   19/344 (5.52%)   37/703 (5.26%)   4/351 (1.14%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
e-mail: clinicaltrials@biogenidec.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00451451     History of Changes
Other Study ID Numbers: 109MS302
Study First Received: March 21, 2007
Results First Received: May 5, 2014
Last Updated: January 13, 2015