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

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Glatiramer Acetate; Drug: BG00012

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451451

109MS302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,417 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

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

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,417 participants in 4 patient groups, including a placebo group

BG00012 240 mg Twice Daily (BID)

Experimental group

Description:

Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)

Treatment:

Drug: Placebo

Drug: BG00012

BG00012 240 mg 3 Times Daily (TID)

Experimental group

Description:

Participants received two 120 mg BG00012 capsules orally three times daily (TID)

Treatment:

Drug: BG00012

Placebo

Placebo Comparator group

Description:

Participants received two placebo capsules orally three times daily (TID)

Treatment:

Drug: Placebo

Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)

Active Comparator group

Description:

Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Treatment:

Drug: Glatiramer Acetate