MSFrontier

CONFIRM

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
CompletedPhase 3Relapsing MSNCT004514512006-003697-10

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“At 2 years, the annualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P<0.001; thrice-daily BG-12, 51%, P<0.001; glatiramer acetate, 29%, P=0.01).”
Read by software from the paper's abstract

annualized relapse rate over a period of 2 years · 2 years

GroupnValue
twice-daily BG-120.22
thrice-daily BG-120.20
glatiramer acetate0.29
placebo0.40

relative reduction vs placebo 44% (twice-daily BG-12); 51% (thrice-daily BG-12); 29% (glatiramer acetate)

p = <0.001 (twice-daily BG-12); P<0.001 (thrice-daily BG-12); P=0.01 (glatiramer acetate)

Read by software from the paper's abstract

What was tested

Treatment tested

Compared with

Placebo or sham

  • Placebo

Results by group

Annualized Relapse Rate

2 years

GroupValueIntervalNumber analysed
Placebo0.401 Relapses Per Year0.329–0.488363
BG00012 240 mg Twice Daily (BID)0.224 Relapses Per Year0.179–0.282359
BG00012 240 mg 3 Times Daily (TID)0.198 Relapses Per Year0.156–0.252345
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)0.286 Relapses Per Year0.232–0.353350

Placebo

0.401

BG00012 240 mg Twice Daily (BID)

0.224

BG00012 240 mg 3 Times Daily (TID)

0.198

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

0.286

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo36379 (21.8%)
BG00012 240 mg Twice Daily (BID)35961 (17.0%)
BG00012 240 mg 3 Times Daily (TID)34454 (15.7%)
Total BG00012703115 (16.4%)
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)35160 (17.1%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annualized Relapse Rate

    2 years

    Disability progressionRelapses

  • Rate of clinical relapses at 2 years

    Relapses

Other measures (4)

  • Number of New or Newly Enlarging T2 Hyperintense Lesions

    2 years

    MRI lesions

  • Number of New T1 Hypointense Lesions

    2 years

    MRI lesions

  • Proportion of Subjects Relapsed

    2 years

    Relapses

  • Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)

    2 years

    Disability progression

Who could take part

Relapsing MS · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Jun 2007

    2. Main results due

      Aug 2011

    3. Finished

      Aug 2011

    4. Results posted

      Jun 2014

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error