MSFrontier

ADVANCE

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
CompletedPhase 3Relapsing MSNCT009063992008-006333-27

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Annualized Relapse Rate (ARR) at 1 YearRate Ratio 0.6440.500–0.8310.0007
Annualized Relapse Rate (ARR) at 1 YearRate Ratio 0.7250.565–0.9300.0114

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Annualized Relapse Rate (ARR) at 1 Year

1 Year

GroupValueIntervalNumber analysed
Year 1: Placebo0.397 relapses per person-years0.328–0.481500
Year 1: Peginterferon Beta-1a Q4W0.288 relapses per person-years0.234–0.355500
Year 1: Peginterferon Beta-1a Q2W0.256 relapses per person-years0.206–0.318512

Year 1: Placebo

0.397

Year 1: Peginterferon Beta-1a Q4W

0.288

Year 1: Peginterferon Beta-1a Q2W

0.256

p = 0.0114; Rate Ratio 0.725 (95% CI 0.565–0.930)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Year 1: Placebo49976 (15.2%)
Year 1: Peginterferon Beta-1a Q4W50070 (14.0%)
Year 1: Peginterferon Beta-1a Q2W51355 (10.7%)
Year 2: Placebo Followed by Peginterferon Beta-1a Q4W22742 (18.5%)
Year 2: Placebo Followed by Peginterferon Beta-1a Q2W22836 (15.8%)
Year 2: Peginterferon Beta-1a Q4W43967 (15.3%)
Year 2: Peginterferon Beta-1a Q2W43839 (8.9%)

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 (ARR) at 1 Year

    1 Year

    Disability progressionRelapses

  • The primary objective of this study is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with relapsing Multiple Sclerosis (MS) at 1 year.

    Relapses

Other measures (3)

  • Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year

    1 Year

    MRI lesions

  • Proportion of Participants Relapsed at 1 Year

    Year 1

    Relapses

  • Estimated Proportion of Participants With Sustained Disability Progression at 1 Year

    1 Year

    Disability progression

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005) * Must have an EDSS score between 0.0 and 5.0. * Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months Key Exclusion Criteria: * Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease * Pregnant or nursing women * Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline 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

The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

Papers

Loading reviews and guidelines…

Linked trials

  • Extended by

    ATTAIN

    Phase 3 · Completed

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

Related trials

History

    1. Started

      Jun 2009

    2. Main results due

      Oct 2012

    3. Finished

      Oct 2013

    4. Results posted

      Sept 2014

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