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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 Idec
ClinicalTrials.gov Identifier:
NCT00451451
First received: March 21, 2007
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
 Drug: BG00012
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1232
Study Start Date: June 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
240 mg (two 120 MG capsules) twice a day
 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: 2
240 mg (two capsules) three times a day.
 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.
Placebo Comparator: 3
placebo
 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.
Active Comparator: 4
glatiramer acetate 20 mg subcutaneous injection once a day.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451451

  Show 206 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided by Biogen Idec

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

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00451451     History of Changes
Other Study ID Numbers: 109MS302
Study First Received: March 21, 2007
Last Updated: November 1, 2012
Health Authority: Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Institutional Review Board
Ukraine: State Pharmacological Center - Ministry of Health
Ireland: Irish Medicines Board
Mexico: Federal Commission for Protection Against Health Risks
Spain: Spanish Agency of Medicines
Estonia: The State Agency of Medicine
Bulgaria: Ministry of Health
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Australia: National Health and Medical Research Council
Greece: National Organization of Medicines
Slovakia: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Croatia: Ministry of Health and Social Care
Canada: Health Canada
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Belgium: Directorate general for the protection of Public health: Medicines
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Biogen Idec:
relapsing
multiple sclerosis
oral
remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Dimethyl fumarate
Copolymer 1
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 19, 2013