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:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00451451
First received: March 21, 2007
Last updated: September 12, 2013
Last verified: September 2011

March 21, 2007
September 12, 2013
June 2007
August 2011   (final data collection date for primary outcome measure)
To determine whether BG00012, when compared with placebo is effective in reducing the rate of clinical relapses at 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To determine whether BG00012, when compared with placebo is effective in reducing the rate of clinical relapses at 2 years.
Complete list of historical versions of study NCT00451451 on ClinicalTrials.gov Archive Site
If BG00012 decreases number of brain lesions, slows time to progression, the safety and tolerability, and effect it has on MS tests and evaluations. Commercially available glatiramer acetate is being used to compare its benefits and risks with placebo. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
There are multiple secondary outcomes.
Not Provided
Not Provided
 
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing-remitting Multiple Sclerosis
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day, glatiramer acetate 20 mg SC injection once a day.
  • Experimental: 1
    240 mg (two 120 MG capsules) twice a day
    Intervention: Drug: BG00012
  • Experimental: 2
    240 mg (two capsules) three times a day.
    Intervention: Drug: BG00012
  • Placebo Comparator: 3
    placebo
    Intervention: Drug: BG00012
  • Active Comparator: 4
    glatiramer acetate 20 mg subcutaneous injection once a day.
    Intervention: Drug: BG00012

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1232
August 2011
August 2011   (final data collection date for primary outcome measure)

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Inclusion Criteria:

  • Aged 18 to 55 years old, inclusive at the time of informed consent
  • Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
  • Must have a baseline EDSS between 0.0 and 5.0, inclusive.
  • Must have relapsing-remitting disease course.

Exclusion Criteria:

  • Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Estonia,   France,   Germany,   Greece,   India,   Ireland,   Israel,   Italy,   Latvia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Moldova, Republic of,   New Zealand,   Poland,   Puerto Rico,   Romania,   Serbia,   Slovakia,   Spain,   Ukraine
 
NCT00451451
109MS302
Yes
Biogen Idec MD, Biogen Idec Inc.
Biogen Idec
Not Provided
Not Provided
Biogen Idec
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP