CompletedPhase 3Relapsing MSNCT010644012009-012500-11

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Adjusted Annualized Relapse Rate (ARR)Rate Ratio 0.5500.469–0.645< 0.0001
Adjusted Annualized Relapse Rate (ARR)Percent Reduction 45.035.5–53.1

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Compared with

Placebo or sham

  • Interferon beta-1a Placebo
  • Daclizumab High Yield Process Placebo

Results by group

Adjusted Annualized Relapse Rate (ARR)

Up to 144 weeks

GroupValueIntervalNumber analysed
Interferon Beta-1a0.393 relapses per person-years0.353–0.438643
Daclizumab High Yield Process0.216 relapses per person-years0.191–0.244402

Interferon Beta-1a

0.393

Daclizumab High Yield Process

0.216

p = < 0.0001; Rate Ratio 0.550 (95% CI 0.469–0.645)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
IFN Beta-1a 30 mcg922194 (21.0%)
DAC HYP 150 mg919221 (24.0%)

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

  • Adjusted Annualized Relapse Rate (ARR)

    Up to 144 weeks

    Disability progressionRelapses
  • • Annualized relapse rate (ARR)

    Relapses

Other measures (5)

  • Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96

    up to 96 weeks

    MRI lesions
  • Proportion of Participants With Sustained Disability Progression at 144 Weeks

    Baseline through 144 weeks

    Disability progression
  • Proportion of Participants Relapse-free at Week 144

    144 weeks

    Relapses
  • Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks

    Baseline and 96 weeks

    Quality of life (reported by participants)
  • a) Number of new or newly-enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) over 96 weeks

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Key Inclusion Criteria: * Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS * Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive * Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment Key Exclusion Criteria: * Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg * History of treatment with Daclizumab High Yield Process (Dac HYP) * History of malignancy * History of severe allergic or anaphylactic reactions * Known hypersensitivity to study drugs or their excipients * History of abnormal laboratory results indicative of any significant disease * History of human immunodeficiency virus (HIV) or other immunodeficient conditions * History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization * History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline * History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1 * An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization * Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus * Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening * Exposure to varicella zoster virus within 21 days before screening 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 study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis. The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Papers

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Linked trials

  • Extended by

    EXTEND

    Phase 3 · Stopped early

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

Related trials

History

    1. Started

      May 2010

    2. Main results due

      Mar 2014

    3. Finished

      Jul 2014

    4. Results posted

      Jul 2016

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